Indications for Use
The ULTRASCORE™ Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.
Contraindications
The ULTRASCORE™ Focused Force PTA Balloon is contraindicated:
• Where there is the inability to cross the target lesion with a guidewire
• For use in the coronary or neuro vasculature.
Warnings
1. Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or re-sterilize. Use the catheter prior to the “Use By” date specified on the package label.
2. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
3. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.
4. To reduce the potential for vessel damage or difficulty in deflating, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis. 5. When the catheter is exposed to the vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip or catheter breakage, catheter kink, or balloon separation.
6. Do not exceed the RBP recommended for this device. Balloon rupture or difficulty in deflation may occur if the RBP rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. .
7After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.
