Charger™ 0.035" Balloon Dilatation Catheter Brief Summary

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

CONTRAINDICATIONS

None Known.

WARNINGS

To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis.
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 catheter unless the balloon is fully deflated under vacuum. If resistance is felt during manipulation, determine the cause of the resistance before proceeding.
Do not exceed the rated balloon burst pressure. The rated burst pressure is based on in vitro testing. At least 99.9 percent of the balloons (with a 95 percent confidence) will not burst at or below their rated burst pressure.
Use only the appropriate balloon inflation medium (typically a 50/50 mixture by volume of contrast medium and sterile saline). Never use air or any gaseous medium to inflate the balloon.
Never advance the dilatation catheter beyond the end of the guidewire or without the aid of a guidewire in order to avoid potential vessel trauma.
The Charger PTA balloon catheter is not for use in the coronary arteries. Any use for procedures other than those indicated in these instructions is not recommended.

PRECAUTIONS

Care should be taken to control the position of the introducer/guide sheath tip during manipulation of the balloon catheter.
The Charger PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these inflation sites.
The Charger PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.
To prevent over pressurization, use of a pressure monitoring device is recommended.
If resistance is felt during post procedure withdrawal of the catheter, it is recommended to extract the entire system with the introducer/guide sheath.
Precautions to prevent or reduce clotting should be taken when any catheter is used: 

• Consider systemic anticoagulation.
• Flush or rinse all products with sterile saline or a similar solution prior to use.

To minimize the possible introduction of air into the system, it is imperative that prior to proceeding, careful attention is paid to the maintenance of tight catheter connections and thorough aspiration and flushing of the system.
Do not advance any portion of the dilatation catheter system against significant resistance. The cause of resistance should be determined via fluoroscopy before proceeding.
Do not pull the balloon protector proximally on to the catheter shaft.

ADVERSE EVENTS

The complications that may result from a balloon dilatation procedure include, but are not limited to:

• Allergic reaction (device, contrast medium and medications)
• Arteriovenous fistula
• Embolization (air, device, plaque, etc.)
• Hematoma
• Hemorrhage, including bleeding at puncture site
• Pseudoaneurysm
• Sepsis/infection
• Thromboembolic episodes
• Vessel injury, e.g. dissection, perforation, rupture
• Vessel occlusion
• Vessel spasm