Boston Scientific Vessix Catheter Mode D'emploi page 3

Contents
Qty Material
1 Vessix™ Catheter
INTENDED USE/INDICATIONS FOR USE
The Vessix Catheter is intended to be used to treat patients with uncontrolled hypertension.
CONTRAINDICATIONS
Contraindications to include those known but not limited to those known for conventional percutaneous interventional procedures.
• The Vessix Catheter is NOT intended for use in any artery other than the renal artery.
• The Vessix Catheter is NOT intended for use in a renal artery that has an implant, nor is it intended to be used in calcified renal arteries.
PRECAUTIONS
• Store in a cool, dry, dark place.
• Protect from direct sunlight and temperatures greater than 104 °F (40 °C) during storage.
• The device should only be used with 0.014 inch or 0.018 inch guide wires.
• Follow instruction for use supplied with the guiding sheath. A thorough understanding of the principles, clinical applications and risks associated
with standard percutaneous procedures is necessary before using this product.
• Minimize torqueing of catheter shaft to avoid potential damage to the catheter.
• Do not reinsert the catheter once it has been removed from the sheath.
• If resistance is encountered during catheter insertion into sheath, do not force passage. Resistance may result in damage to the balloon circuitry
if it is forced. If significant resistance is encountered, remove the catheter.
ADVERSE EVENTS
The following adverse events could possibly occur as a result of the use of the catheter, but are not limited to:
• Renal artery dissection or perforation
• Renal artery spasm
• Hypotension
• Acute closure of renal artery
• Thrombus in renal artery
• Stenosis in the renal artery
• Hematoma at access site
• Embolization
• Pyrogenic reaction
• Kidney malfunction
• Access site infection
• Hemorrhage
• Pain
HOW SUPPLIED
Sterile: The Vessix Catheter is supplied sterile. The device is sterilized by electron-beam radiation.
HANDLING AND STORAGE
Temperature:
• Operating temperature: 10 °C (50 °F) - 40 °C (104 °F)
• Storage temperature: 10 °C (50 °F) - 40 °C (104 °F)
• Transport temperature: -10 °C (14 °F) - 50 °C (122 °F)
Humidity:
• 30% - 75% RH, non-condensing
OPERATIONAL INSTRUCTIONS
A. Additional Materials and Equipment
• Guiding sheath in the appropriate size and configuration to access the renal artery
• Tuohy-Borst "y" adapter or hemostatic valve(s)
• Normal heparinized saline
• Standard contrast media
• Guide wires
B. Compatibility
• Only use the Vessix™ Generator. Do not use any other RF generator.
• Catheter Rated Voltage: 100 Vrms.
• Vessix Catheters must be used with either a 0.014 inch or 0.018 inch guide wire.
• All Vessix Catheter sizes, 4.0 mm, 5.0 mm, 6.0 mm, and 7.0 mm are recommended to be used with the following guiding sheath:
• Cook Medical Flexor Ansel Check-Flo
®
Model # G49100 (KCFW-8.0-18/38-45-RB-ANL1-HC).
8F Guiding Sheath with inner diameter of 0.113 inch (2.87 mm),
®
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Black (K) ∆E ≤5.0