The C-code used for this product is C1725
, Catheter, transluminal angioplasty, non-laser. C-codes are used for hospital outpatient device reporting for Medicare and some private payers.
Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice.
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.
Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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. Charger Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.
The Charger PTA Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty. 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 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.)
- Hemorrhage, including bleeding at puncture site
- Thromboembolic episodes
- Vessel injury, e.g. dissection, perforation, rupture
- Vessel occlusion
- Vessel spasm.
Additionally, the following complications may result from a balloon dilatation procedure within the biliary system:
- Duct injury, e.g. dissection, perforation, rupture
- Duct occlusion
- Duct spasm.