INTENDED USE
The Advance Serenity 14 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
CONTRAINDICATIONS
No contraindications known for PTA procedure. The Advance Serenity 14 Hydrophilic PTA Balloon Dilatation Catheter is contraindicated for use in the coronary arteries and the neurovasculature.
WARNINGS
• This device is intended for single use only; do not reuse. Do not re-sterilize, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
• To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis in Percutaneous Transluminal Angioplasty (PTA).
• When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.
• Do not advance or retract the device unless the balloon is fully deflated under vacuum.
• If resistance is met during manipulation, determine the cause of the resistance before proceeding.
• Balloon pressure should not exceed the rated burst pressure (RBP). Refer to the product label for device specific information. The RBP is based on results of in vitro testing. At least 99.9% of the balloons (with a
95% confidence) will not burst at or below their RBP. To prevent over pressurization, use a pressure monitoring device.
• Inflation at a high rate may damage the balloon.
• Use only clinically recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
• Do not use with Lipiodol contrast media, or other such contrast media which incorporate the components of this agent.
• Do not use after the “use by date” specified on the package.
• Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead prepare a new catheter.
PRECAUTIONS
• A thorough understanding of the principles, clinical applications and risk associated with PTA is necessary before using this product.
• This device is not recommended for applications that may require inflation higher than those recommended for this catheter.
• Do not use if package is open or damaged.
• Prior to use, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
• During the procedure, appropriate anti-coagulant therapy must be provided to the patient as needed. Anti-coagulant therapy should be continued for a period of time to be determined by the physician after the procedure.
• Consider the use of systemic heparinization. Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.
• The minimal acceptable sheath French size is indicated on the package label. Do not attempt to pass the PTA catheter through a smaller size introducer sheath than indicated on the label.
• Not intended for precise arterial blood pressure monitoring.
• Do not advance or withdraw the PTA catheter within the vasculature unless the catheter is preceded by a wire guide.
• Do not use for procedures other than those indicated in this Instructions for Use.
