INDICATIONS FOR USE
This device is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculature.
- Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.
- This device should be used only by physicians with a thorough understanding of angiography and/or percutaneous neurointerventional procedures.
- Inspect the catheter prior to use for any kinks or bends. Any catheter damage may decrease the desired performance characteristics.
Guidewire: ≤ 0.021" (0.053 mm)
Potential complications include, but are not limited to, the following:
- Distal emboli (air, foreign material, tissue, or thrombus)
- Pain at insertion site
- Neurological deficit that could lead to stroke and death
- Vessel spasm, dissection, perforation or injury
- THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. Discard after one procedure. Structural integrity and/or function may be impaired after reuse or cleaning.
- The catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
- Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.
- Static pressure for this catheter should not exceed 400 psi.
- This device is supplied STERILE for single use only. Do not reprocess or re-sterilise. Reprocessing and re-sterilisation increase the risks of patient infection and compromised device performance.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.
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