Definition: A Drug-eluting Peripheral Transluminal Angioplasty Catheter Is A Combination Product Intended For Balloon Dilatation Of Peripheral Vasculature To Establish Or Maintain Patency. A Drug-eluting PTA Catheter Delivers A Drug To The Vessel As Part Of The
| Device Type ID | 1071 |
| Device Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Physical State | The Balloon Catheter Is Generally Constructed Of Synthetic Materials Such As Plastic And Introduced Into The Body Using A Guidewire. The Balloon Is Generally Manufactured In Multiple Diameters And Lengths To Allow For Treatment Of Different Lesion Si |
| Technical Method | The Balloon Catheter Uses Mechanical Force Across A Lesion To Establish Patency. The Drug Coating Serves As An Adjunct To The Mechanical Action Of Balloon Angioplasty And Assists In Maintaining Vessel Patency Post-procedure. |
| Target Area | Lesions In Peripheral Arteries Including Iliac, Popliteal, Femoral, And Iliofemoral |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | ONU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1071 |
| Device | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Product Code | ONU |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1406 |
Inflation Problem | 97 |
Material Rupture | 85 |
Defective Device | 64 |
Burst Container Or Vessel | 46 |
Balloon | 30 |
Difficult To Remove | 26 |
Deflation Problem | 24 |
Leak / Splash | 22 |
Detachment Of Device Or Device Component | 15 |
Material Twisted / Bent | 13 |
Retraction Problem | 9 |
Material Deformation | 9 |
Torn Material | 7 |
Device-Device Incompatibility | 6 |
Occlusion Within Device | 6 |
Device Expiration Issue | 5 |
Difficult To Advance | 5 |
Shaft | 3 |
Material Split, Cut Or Torn | 3 |
Scratched Material | 2 |
Insufficient Information | 2 |
Stretched | 2 |
Off-Label Use | 2 |
Material Perforation | 1 |
Fluid Leak | 1 |
Break | 1 |
Crack | 1 |
Device Markings / Labelling Problem | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Stent | 1 |
Device Operates Differently Than Expected | 1 |
Fracture | 1 |
| Total Device Problems | 1899 |