Panel Questions for the Circulatory Systems Devices Panel
of the Medical Devices Advisory Committee
December 4-5, 2000
Questions for the Panel (PTCA Reclassification Petition)
1) Does the proposed classification description sufficiently describe the percutaneous transluminal coronary angioplasty (PTCA) catheter?
Proposed Device Description
A PTCA balloon catheter has a single or double lumen shaft with a balloon near the distal tip. The catheter typically features a minimally compliant balloon constructed from a high density polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with acceptable rates of inflation and deflation and acceptable burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use.
2) Have the health risks associated with PTCA catheters been adequately identified? If not, what are the additional risks that should be described?
Identified Health Risks
- Acute Vessel Closure
- Coronary Artery Dissection, Perforation, Rupture
- Aneurysm Formation
- Acute MI and Unstable Angina
- Vascular Access Site Complications
- Coronary Artery Spasm
- Embolization or Fragmentation of Thrombotic or Atherosclerotic Material
- Emergency Bypass Surgery
- Balloon Rupture
- Guidewire Fracture or Entrapment
- Reaction to Contrast Agent
- Failed Procedure
3) Have appropriate special controls been identified to adequately address the risks to health specific to PTCA catheters? If not, what additional special controls are necessary to reclassify PTCA catheters?
Proposed Special Controls
- Guidance Document
- Device Labeling
(Uploaded November 9, 2000)