Definition: To Reduce Coronary Artery Stenosis By Dilatation Of The Balloon And By Apposition Of The Cutting/scoring Surfaces To The Stenotic Material For The Treatment Of Coronary Artery Stenosis To Improve Myocardial Perfusion.
| Device Type ID | 1061 |
| Device Name | Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring |
| Physical State | Cutting/scoring PTCA Catheters Are Usually Comprised Of Flexible Polymers For The Catheter Body And A Compliant Polymer For The Balloon. The Cutting/scoring Elements Are Usually Metal. |
| Technical Method | The Device Functions Independently, But Is Typically Placed Using A Guidewire And Guiding Catheter. The Balloon Is Inflated By The Infusion Of Liquid Through The Body Of The Catheter. Following Treatment, The Liquid Is Withdrawn, The Balloon Is Defla |
| Target Area | Coronary Arteries. |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NWX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1061 |
| Device | Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring |
| Product Code | NWX |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Material Rupture | 955 |
Balloon | 818 |
Break | 112 |
Shaft | 97 |
Catheter | 91 |
Failure To Advance | 74 |
Detachment Of Device Component | 58 |
Difficult To Remove | 38 |
Leak / Splash | 34 |
Cutter | 31 |
Detachment Of Device Or Device Component | 29 |
Entrapment Of Device | 23 |
Device Damaged Prior To Use | 19 |
Material Deformation | 17 |
Inflation Problem | 16 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Deflation Problem | 12 |
Kinked | 10 |
Difficult To Advance | 10 |
Fracture | 8 |
Tip | 6 |
Fluid Leak | 6 |
Hole In Material | 5 |
Device Dislodged Or Dislocated | 5 |
Defective Component | 3 |
Material Separation | 3 |
Stretched | 3 |
Torn Material | 2 |
Device Damaged By Another Device | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Peeled / Delaminated | 2 |
Material Integrity Problem | 2 |
Bent | 2 |
Burst Container Or Vessel | 2 |
Material Puncture / Hole | 2 |
Retraction Problem | 2 |
Use Of Device Problem | 1 |
Component Missing | 1 |
No Apparent Adverse Event | 1 |
No Display / Image | 1 |
Unraveled Material | 1 |
Protector | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Device-Device Incompatibility | 1 |
Physical Resistance / Sticking | 1 |
Device Packaging Compromised | 1 |
Stylet | 1 |
Failure To Unfold Or Unwrap | 1 |
Material Perforation | 1 |
Device Or Device Fragments Location Unknown | 1 |
Mechanical Problem | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Device Markings / Labelling Problem | 1 |
| Total Device Problems | 2536 |