Indications

The Chameleon™ PTA balloon catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon™ PTA balloon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

Contraindications

DO NOT use the Chameleon™ PTA balloon:

  • For coronary arteries nor for the delivery and/or expansion of stents.
  • In patients who cannot tolerate anticoagulation therapy. 
Warnings
 
  • Single patient use only. Do not re-use, re-process or re-sterilize.
  • Use the recommended balloon inflation medium. DO NOT use air or any other gaseous medium (e.g. CO2) to inflate the balloon or for infusion through the catheter.
  • When the catheter is exposed to the vascular system, it should be manipulated only while under high-quality fluoroscopic observation.
  • DO NOT manipulate the catheter unless the balloon is fully deflated. Never advance / withdraw against any resistance. DO NOT use excessive force. If resistance is felt, determine the cause and take any necessary remedial action. Applying excessive force to the catheter may lead to tissue trauma and / or device damage.
  • DO NOT exceed the RBP recommended on the product label. Balloon rupture may occur if the RBP rating is exceeded. To prevent over pressurization, use an inflation device with manometer.
Contraindications
 
  • Only physicians trained in the performance of PTA procedures should use the Chameleon™ PTA balloon.
  • The minimal acceptable sheath French size is printed on the product label. DO NOT attempt to pass the catheter through a sheath size smaller than that indicated on the product label.
  • The recommended guide wire size is printed on the package label. DO NOT attempt to use the catheter without a guide wire or with a different size other than the one indicated on the label.
  • If resistance is felt during post procedure withdrawal of the catheter, confirm that the balloon is fully deflated and only then remove the balloon catheter, the guide wire and the introducer sheath as a single unit.
Potential Adverse Reactions
 
Complications from a peripheral balloon dilatation procedure may include:
 
  • Allergic reaction to drugs or contrast medium
  • Aneurysm or pseudo-aneurysm
  • Arrhythmias
  • Embolization
  • Hematoma
  • Hemorrhage, including bleeding at the puncture site
  • Hypotension / hypertension
  • Inflammation
  • Need for additional intervention
  • Occlusion
  • Pain or tenderness
  • Pneumothorax or Hemothorax
  • Sepsis / infection
  • Shock
  • Short term hemodynamic deterioration
  • Stroke
  • Thrombosis
  • Vessel dissection, perforation, rupture or spasm

  • CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.