Radiofrequency (RF) Ablation Catheters
- RF Marinr Unipolar Steerable Ablation Catheter
- 5Fr RF Marinr Steerable Catheter
- RF Contactr Steerable Ablation Catheter
- RF Enhancr II Steerable Ablation Catheter
- RF Conductr Steerable Ablation Catheter
Diagnostic Catheters
- Soloist Intracardiac Electrode Catheter
- StableMapr Steerable/ Deflectable Tip Electrode Catheter
- Torqr Electrode Catheters
- Marinr Catheters
Introducer Sheaths and Needles
RF Generators
Radiofrequency (RF) Ablation Catheters
- RF Marinr Unipolar Steerable Ablation Catheter
- 5Fr RF Marinr Steerable Catheter
- RF Contactr Steerable Ablation Catheters
- RF Enhancr II Steerable Ablation Catheter
- RF Conductr Steerable Ablation Catheter
RF marinR unipolar STEERABLE ABLATION CATHETER
INDICATIONS FOR USE
The RF Marinr Unipolar catheter is intended for use with the Medtronic RF power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
CONTRAINDICATIONS
Contraindications for the RF Conductr ablation catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of a catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for left-sided cardiac procedure, or who have had recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
WARNINGS/PRECAUTIONS
General
Related product literature – Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use.
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
Qualified users – The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF ablation generator.
Required use environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.
Ablation therapy hazards
Serious adverse events – A number of serious adverse events have been documented for catheter ablation procedures, including pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; and death. See the “Adverse events” section for additional potential adverse events.
Left-sided ablation procedures – Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
Distal pair electrode spacing of >2 mm – Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
Catheter manipulation and placement – Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.
X-ray and fluoroscopic exposure – Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. The long-term effects of protracted fluoroscopy have not been established.
- Minimize x-ray exposure.
- Carefully consider the use of the device in pregnant women and prepubescent children.
AV conduction – Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 μA under any circumstances.
Catheter removal – See your Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
Long-term risk – The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
Emergency use – In the event of an emergency, do not use the RF Marinr Unipolar catheter to sustain the patient’s life. Patient death or injury may occur.
Flammable materials – Do not allow flammable material in the area where RF ablation procedures are performed. The risk of igniting flammable gases, flammable agents used for cleaning or disinfecting, or other materials is inherent in the application of RF energy.
Placement of monitoring electrodes – Place all physiological monitoring electrodes as far away as possible from the patient return electrodes and their leads to avoid RF interference, which affects the ability to interpret patient electrograms (EGMs).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
5Fr rf MARINR STEERABLE CATHETER
INDICATIONS FOR USE
The RF Marinr catheter is intended for use with a Medtronic RF power generator to deliver RF energy for intracardiac radiofrequency ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
CONTRAINDICATIONS
Contraindications for the RF Marinr steerable electrode catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
WARNINGS/PRECAUTIONS
General
Related product literature – Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use.
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
Qualified users – The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF power generator.
Required use environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.
Ablation therapy hazards
Hazards related to the 1.67 mm (5 Fr) RF Marinr catheter – Read carefully
- Performing ablation from within the coronary sinus and its venous branches with a 1.67 mm (5 Fr) RF Marinr catheter may present additional safety risks because of the increased likelihood of injuring adjacent coronary arterial structures.
- Due to the smaller diameter of the 1.67 mm (5 Fr) RF Marinr catheter, lesion dimensions may be smaller as compared to using a 2.33 mm (7 Fr) or 2.67 mm (8 Fr) ablation system at similar power outputs.
- During in vitro testing with a 1.67 mm (5 Fr) RF Marinr catheter under no flow conditions, this catheter demonstrated an increased frequency of temperature shutdowns
Serious adverse events – A number of serious adverse events have been documented for catheter ablation procedures, including pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; and death. See the “Adverse events” section for additional potential adverse events.
Left-sided ablation procedures – Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
Distal pair electrode spacing of >2 mm – Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
Catheter manipulation and placement – Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.
X-ray and fluoroscopic exposure – Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. The long-term effects of protracted fluoroscopy have not been established.
- Minimize x-ray exposure.
- Carefully consider the use of the device in pregnant women and prepubescent children.
AV conduction – Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 μA under any circumstances.
Catheter removal – See your Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
Long-term risk – The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
Emergency use – In the event of an emergency, do not use the RF Marinr Unipolar catheter to sustain the patient’s life. Patient death or injury may occur.
Flammable materials – Do not allow flammable material in the area where RF ablation procedures are performed. The risk of igniting flammable gases, flammable agents used for cleaning or disinfecting, or other materials is inherent in the application of RF energy.
Placement of monitoring electrodes – Place all physiological monitoring electrodes as far away as possible from the patient return electrodes and their leads to avoid RF interference, which affects the ability to interpret patient electrograms (EGMs).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
RF CONTACTR STEERABLE ABLATION CATHETER
INDICATIONS FOR USE
The RF Contactr catheter is intended for use with a Medtronic RF power generator to deliver RF energy for intracardiac radiofrequency ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
CONTRAINDICATIONS
Contraindications for the RF Marinr steerable electrode catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
WARNINGS/PRECAUTIONS
General
Related product literature – Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use.
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
Qualified users –The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF ablation generator.
Required use environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.
Ablation therapy hazards
Left-sided ablation procedures – Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
Distal pair electrode spacing of >2 mm – Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
Catheter manipulation and placement – Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.
X-ray and fluoroscopic exposure – Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. The long-term effects of protracted fluoroscopy have not been established.
- Minimize x-ray exposure.
- Carefully consider the use of the device in pregnant women and prepubescent children.
AV conduction – Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 μA under any circumstances.
Catheter removal – See your Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
Long-term risk – The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
Emergency use – In the event of an emergency, do not use the RF Marinr Unipolar catheter to sustain the patient’s life. Patient death or injury may occur.
Flammable materials – Do not allow flammable material in the area where RF ablation procedures are performed. The risk of igniting flammable gases, flammable agents used for cleaning or disinfecting, or other materials is inherent in the application of RF energy.
Placement of monitoring electrodes – Place all physiological monitoring electrodes as far away as possible from the patient return electrodes and their leads to avoid RF interference, which affects the ability to interpret patient electrograms (EGMs).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
RF ENHANCR II Steerable Ablation Catheter
INDICATIONS FOR USE
The RF Enhancr II catheter is indicated for use with the Medtronic RF power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
CONTRAINDICATIONS
Contraindications for the RF Marinr steerable electrode catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
Warnings/Precautions
General
Related product literature – Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use.
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
Qualified users – The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF ablation generator.
Required use environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.
Ablation therapy hazards
Serious adverse events – A number of serious adverse events have been documented for catheter ablation procedures, including pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; and death. See the “Adverse events” section for additional potential adverse events.
Left-sided ablation procedures – Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
Distal pair electrode spacing of >2 mm – Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
Catheter manipulation and placement – Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.
X-ray and fluoroscopic exposure – Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. The long-term effects of protracted fluoroscopy have not been established.
- Minimize x-ray exposure.
- Carefully consider the use of the device in pregnant women and prepubescent children.
AV conduction – Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 μA under any circumstances.
Catheter removal – See your Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
Long-term risk – The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
Emergency use – In the event of an emergency, do not use the RF Marinr Unipolar catheter to sustain the patient’s life. Patient death or injury may occur.
Flammable materials – Do not allow flammable material in the area where RF ablation procedures are performed. The risk of igniting flammable gases, flammable agents used for cleaning or disinfecting, or other materials is inherent in the application of RF energy.
Placement of monitoring electrodes – Place all physiological monitoring electrodes as far away as possible from the patient return electrodes and their leads to avoid RF interference, which affects the ability to interpret patient electrograms (EGMs).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
RF Conductr STEERABLE ABLATION CATHETER
INDICATIONS FOR USE
The RF Conductr Catheter is intended for use with Medtronic RF power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, for creation of complete AV block in patients with difficult to control ventricular response to an atrial arrhythmia, and for the treatment of atrial flutter.
CONTRAINDICATIONS
Contraindications for the RF Conductr ablation catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of a catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for left-sided cardiac procedure, or who have had recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
WARNINGS/PRECAUTIONS
General
Related product literature –Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use.
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
Qualified users –The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF ablation generator.
Required use environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.
Ablation therapy hazards
Serious adverse events –A number of serious adverse events have been documented for catheter ablation procedures, including pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; and death. See the “Adverse events” section for additional potential adverse events.
Left-sided ablation procedures –Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
Distal pair electrode spacing of >2 mm –Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
Catheter manipulation and placement –Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.
X-ray and fluoroscopic exposure –Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. The long-term effects of protracted fluoroscopy have not been established.
· Minimize x-ray exposure.
· Carefully consider the use of the device in pregnant women and prepubescent children.
AV conduction –Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.
Leakage current –Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 μA under any circumstances.
Catheter removal –See your Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
Long-term risk –The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
Emergency use –In the event of an emergency, do not use the RF Marinr Unipolar catheter to sustain the patient’s life. Patient death or injury may occur.
Flammable materials –Do not allow flammable material in the area where RF ablation procedures are performed. The risk of igniting flammable gases, flammable agents used for cleaning or disinfecting, or other materials is inherent in the application of RF energy.
Placement of monitoring electrodes –Place all physiological monitoring electrodes as far away as possible from the patient return electrodes and their leads to avoid RF interference, which affects the ability to interpret patient electrograms (EGMs).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
Soloist Intracardiac Electrode Catheter
INDICATIONS FOR USE
The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Contraindications
Contraindications for the Soloist intracardiac electrode catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
Warnings/Precautions
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF
power generators or accessories has not been tested. Use only Medtronic cables.
Catheter use – Do not use this catheter for intracardiac ablation or for DC ablation.
Qualified users – The catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including
the placement and use of intracardiac electrode catheters.
Potential risk and complications – Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or
systemic infection, and death.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any
connected device to the patient must not exceed 10 μA under any circumstances.
Coronary sinus use only – Do not use in the coronary vasculature other than in the coronary sinus.
Storage conditions – Store the catheter in normal operating room temperatures and humidity levels and in a manner that protects the integrity of the package and the sterile barrier. Keep dry. The catheter has the following storage temperature limits: - 30 °C (-22 °F) to 60 °C (140 °F), maximum relative humidity of 80%.
Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the sterile packaging or the catheter exhibits damage, do not use the catheter. Contact your local Medtronic representative.
For single use only – This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
Sterilization – Medtronic has sterilized the package contents using irradiation before shipment. This device is for single use only and is not intended to be resterilized.
Disposal of catheter – Dispose of the catheter according to hospital biohazard requirements. If returning the catheter, contact your local Medtronic representative.
Catheter handling and care –
- Do not excessively bend or kink the catheter. Excessive bending or kinking may damage internal electrode wires and/or distal tip shaping capabilities.
- Do not allow moisture onto the connectors on the catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly.
- Do not wipe the catheter with organic solvents, such as alcohol, to maintain optimal patient safety and catheter electrode integrity.
- Do not resterilize or reuse Medtronic catheters, which are disposable and intended for single use only. Reuse may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another.
Magnetic resonance imaging (MRI) – Catheter materials are not compatible with magnetic resonance imaging (MRI).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
Stablemapr Steerable/ Deflectable tip electrode catheter
INDICATIONS FOR USE
The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
CONTRAINDICATIONS
Contraindications for the StableMapr steerable intracardiac electrode catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
WARNINGS/PRECAUTIONS
System compatibility – Use only connecting cables supplied by Medtronic or patient injury, operator injury, or equipment damage may occur.
Qualified users – The catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including placement and use of intracardiac electrode catheters.
Potential risk and complications – Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection and death.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any
connected device to the patient must not exceed 10 μA under any circumstances.
Storage conditions – Store the catheter in normal operating room temperatures and humidity levels and in a manner that protects the integrity of the package and the sterile barrier. Keep dry. The catheter has the following storage temperature limits: - 30 °C (-22 °F) to 60 °C (140 °F), maximum relative humidity of 80%.
Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the sterile packaging or the catheter exhibits damage, do not use the catheter. Contact your local Medtronic representative.
For single use only – This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
Sterilization – Medtronic has sterilized the package contents using irradiation before shipment. This device is for single use only and is not intended to be resterilized.
Disposal of catheter – Dispose of the catheter according to hospital biohazard requirements. If returning the catheter, contact your local Medtronic representative.
Catheter use – Do not use this catheter for intracardiac ablation or for DC ablation.
Catheter handling and care -
Do not allow moisture onto the connectors on the catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly.
- Do not excessively bend or kink the catheter. Excessive bending or kinking may damage internal electrode wires and/or distal tip shaping capabilities
- Do not allow moisture onto the connectors on the catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly
- Do not wipe the catheter with organic solvents, such as alcohol,to maintain optimal patient safety and catheter electrode integrity
- Do not resterilize or reuse Medtronic catheters, which are disposable and intended for single use only. Reuse may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious
diseases from one patient to another.nous filtering device (Greenfield Filter)
Magnetic resonance imaging (MRI) – Catheter materials are not compatible with magnetic resonance imaging (MRI).
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
Torqr Catheters
- Torqr Quadrapolar Fixed-Curve Catheters
- Torqr CS Fixed-Curve Decapolar Catheters
INDICATIONS FOR USE
The Medtronic Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
CONTRAINDICATIONS
Contraindications for the Torqr Intracardiac Electrode Catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
Warnings/Precautions
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
Catheter use – Do not use this catheter for intracardiac ablation or for DC ablation. United States law does not permit the use of this catheter for these types of ablation.
Qualified users – The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF ablation generator.
Potential risk and complications – Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection, and death.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 μA under any circumstances.
Storage conditions – Store the catheter in normal operating room temperatures and humidity levels and in a manner that protects the integrity of the package and the sterile barrier. Keep dry. The catheter has the following storage temperature limits: -30 °C (-22 °F) to 60 °C (140 °F), maximum relative humidity of 80%.
Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the sterile packaging or the catheter exhibits damage, do not use the catheter. Contact your local Medtronic
representative.
For single use only – This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
Sterilization – Medtronic has sterilized the package contents using irradiation before shipment. This device is for single use only and is not intended to be resterilized.
Disposal of catheter – Dispose of the catheter according to hospital biohazard requirements. If returning the catheter, contact your local Medtronic representative.
Catheter handling and care –
- Do not excessively bend or kink the catheter. Excessive bending or kinking may damage internal electrode wires and/or distal tip shaping capabilities.
- Do not allow moisture onto the connectors on the catheter,Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly.
- Do not wipe the catheter with organic solvents, such as alcohol, to maintain optimal patient safety and catheter electrode integrity.
- Do not resterilize or reuse Medtronic catheters, which are disposable and intended for single use only. Reuse may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another.
Magnetic resonance imaging (MRI) – Catheter materials are not compatible with magnetic resonance imaging (MRI)
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
Marinr Catheters
- Marinr Steerable/ Deflectable Tip Electrode Catheter
- Marinr MC and MCXL Steerable Deflectable Tip Electrode Catheter
- Marinr SC Steerable Quadrapolar Catheter
INDICATIONS FOR USE
The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
CONTRAINDICATIONS
Contraindications for the Marinr Steerable Electrode Catheter include the following conditions:
- Active sepsis
- Known sensitivity to heparin
- Blood clotting abnormalities
- Venous filtering device (Greenfield Filter)
- Use of catheter in an obstructed or damaged vessel
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
WARNINGS/PRECAUTIONS
System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only
Medtronic cables.
Catheter use – Do not use this catheter for intracardiac ablation or for DC ablation.
Qualified users – The catheter should be used only by or under the supervision of physicians trained in ablation procedures using this catheter and the Medtronic RF ablation generator.
Potential risk and complications – Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to the following: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax,
local or systemic infection, and death.
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any
connected device to the patient must not exceed 10 μA under any circumstances.
Storage conditions – Store the catheter in normal operating room temperatures and humidity levels and in a manner that protects the integrity of the package and the sterile barrier. Keep dry. The catheter has the following storage temperature limits: - 30 °C (-22 °F) to 60 °C (140 °F), maximum relative humidity of 80%.
Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the sterile packaging or the catheter exhibits damage, do not use the catheter. Contact your local Medtronic representative.
For single use only – This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
Sterilization – Medtronic has sterilized the package contents using irradiation before shipment. This device is for single use only and is not intended to be resterilized.
Disposal of catheter – Dispose of the catheter according to hospital biohazard requirements. If returning the catheter, contact your local Medtronic representative.
Catheter handling and care -
- Do not excessively bend or kink the catheter. Excessive bending or kinking may damage internal electrode wires and/or distal tip shaping capabilities. Marinr Technical Manual English 13
- Do not allow moisture onto the connectors on the catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly
- Do not wipe the catheter with organic solvents, such as alcohol, to maintain optimal patient safety and catheter electrode integrity
- Do not resterilize or reuse Medtronic catheters, which are disposable and intended for single use only. Reuse may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another
Magnetic resonance imaging (MRI) – Catheter materials are not compatible with magnetic resonance imaging (MRI)
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
Brockenbrough Curved Needles
The Medtronic Brockenbrough™ curved needle is made up of an outer cannula and an inner stylet. The outer cannula is made of flexible thin-walled tubing. The inner stylet is solid, much stiffer and closely fitting, whose sharpened end protrudes 2-3 mm beyond the tip of the cannula.
INDICATIONS FOR USE
The Brockenbrough curved needle is used in conjunction with transseptal catheters to puncture the atrial septum to allow conducting a left heart catheterization procedure through the right atrium. The Brockenbrough curved needle is intended for single use only.
CONTRAINDICATIONS
The use of the Brockenbrough curved needle is contraindicated in patients with the following conditions:
- Distorted anatomy due to congenital heart disease
- Significant chest or spine deformity
- The inability to lie flat
- Ongoing anticoagulation
- Marked atrial enlargement
- Left atrial thrombus or tumor
- Dilated aortic root
- Previous patch repair of the interatrial septum
WARNINGS/PRECAUTIONS
- The Brockenbrough curved needle is designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this needle should be restricted to those specialists trained to perform transseptal procedures to minimize the complications associated with this procedure.
- The Brockenbrough curved needle must be sharp to minimize the risk of puncturing the left atrial wall just after crossing the septum.
- Use continuous pressure monitoring and repeated biplane fluoroscopy of the tip during any positioning, to minimize the risk of advancing the Brockenbrough curved needle into an undesired location and the subsequent bleeding that might occur.
- Extreme caution should be used in patients with a small left atrium, to avoid puncture of the left atrial wall.
- Never advance the Brockenbrough curved needle until the catheter is correctly positioned on the atrial septum to minimize the risk of advancing the needle into an undesired location.
- Never advance a dilator, sheath or catheter until the Brockenbrough curved needle has clearly entered the left atrial cavity, as confirmed by a distinct left atrial pressure record and the tip of the needle is in the left atrium on fluoroscopy.
- If a dilator, sheath or catheter are inadvertently advanced into the pericardial space, do not remove them until the patient is in surgery.
- Do not reuse the Brockenbrough curved needle. The Brockenbrough curved needle must be discarded after one procedure. Its structural integrity and/or function can be impaired through reuse or cleaning. All parts are extremely difficult to clean after being exposed to biological materials, and adverse patient reactions can result from reuse.
- For single use only. This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
- The Brockenbrough curved needle has been gamma sterilized prior to shipment. Carefully inspect the package before opening. Damaged packages should be returned to Medtronic. The Brockenbrough curved needle cannot be resterilized.
- Do not use the product after its expiration date.
- At no time should the introducer or guide wire be advanced or withdrawn when resistance is met without first determining the cause by fluoroscopy and taking remedial action.
- Ensure that the catheter is appropriate for the Brockenbrough curved needle being used.
- After use, the Brockenbrough curved needle may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
Mullins Transseptal Introducer Catheter
The Medtronic Transseptal Catheter Introducer Sheaths are available in two designs:
Mullins Transseptal Catheters Product Description
Mullins Transseptal Catheter Introducer Set The Mullins transseptal catheter introducer set consists of a long radiopaque sheath and dilator. The distal section is curved to accommodate the curved Brockenbrough™ needle and to enable positioning against the atrial septum
Medtronic Transseptal Catheters Product Description
Medtronic Transseptal Catheter Introducer Set is the same as the Mullins Transseptal Catheter Introducer Set except that the Medtronic transseptal introducer sheath contains a gasket seal assembly within the hub to minimize blood loss during catheter introduction or exchange, and a sideport for fluid infusion, blood sampling, or pressure monitoring. In addition, the sideport has a three-way stopcock attached.
Contraindications
The introducer sets are contraindicated for use under these conditions:
- Known or suspected left atrial myxoma
- Previous systemic embolization from left side of the heart
- Previous intra-atrial septal pouch
Warnings
- Do not advance the dilator or sheath through the interatrial septum without first observing an acceptable left atrial pressure tracing. Advancing the dilator or sheath too quickly could cause placement in an undesired location or subsequent bleeding.
- Use repeated biplane fluoroscopy of the tip during any positioning to prevent advancing the device into an undesired location and the subsequent bleeding that might occur.
- Maintain continuous pressure monitoring and repeated anterior-posterior and lateral visualization under fluoroscopy throughout the procedure.
- Withdraw each component slowly to help prevent a vacuum in the sheath. Do not apply suction directly to the sheath. If blood does not flow freely from the sheath, it suggests that the distal end opening is against the wall of the atrium or against a pulmonary vein. Withdraw the sheath approximately 1 finger width until flow is reestablished.
- This device is for single use. Reuse of this device creates a potential risk of patient or user infections due to contamination. Contamination of the device may lead to injury, illness or death of the patient. Reuse, Reprocessing, resterilization may compromise the structural integrity of the device.
- The Medtronic and Mullins transseptal catheter introducer sets are designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this device should be restricted to those specialists trained to perform transseptal procedures.
- Aspiration is recommended when withdrawing the catheter or dilator to remove any fibrin deposition that may have accumulated in or on the tip of the sheath. Aspiration helps prevent embolization of the fibrin and the subsequent ischemia that might occur.
- Perform frequent aspirations and saline flushing of the sheath, dilator, and catheter to help minimize the potential for air emboli.
- For Medtronic Transseptal Set Only: It is essential to aspirate all air from the infusion sideport before infusion through the side port or the introduction of a catheter. Aspiration helps prevent an air embolus and the subsequent ischemia that might occur.
- For Medtronic Transseptal Set Only: A continuous drip under pressure is required through the sideport when the introducer is left in the vessel.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
ATKAR PLUS GENERATOR
INDICATIONS
See the technical manual for the catheter you are using.
CONTRAINDICATIONS
See the technical manual for the catheter you are using.
POTENTIAL ADVERSE EVENTS
See the technical manual for the catheter you are using.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu