| Device |
catheters, transluminal coronary angioplasty, percutaneous |
| Regulation Description |
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. |
| Definition |
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. |
| Product Code | LOX |
| Regulation Number |
870.5100
|
|---|
| Device Class |
2
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
19
|
22
|
28
|
30
|
2
|
0
|
0
|
|
| Device Problems |
| Balloon rupture |
1935 |
| Material rupture |
1343 |
| Deflation issue |
355 |
| Difficult to remove |
289 |
| Shaft break |
253 |
| No Known Device Problem |
228 |
| Balloon burst |
223 |
| Unknown (for use when the device problem is not known) |
156 |
| Break |
147 |
| Inflation issue |
142 |
| Failure to advance |
137 |
| Burst |
102 |
| Kinked |
97 |
| Detachment of device component |
95 |
| Leak |
89 |
| Other (for use when an appropriate device code cannot be identified) |
75 |
| Physical resistance |
72 |
| Detachment of device or device component |
69 |
| Foreign material present in device |
68 |
| Entrapment of device or device component |
68 |
| Balloon leak(s) |
60 |
| Fracture |
59 |
| Use of Device Issue |
52 |
| Visibility/palpability |
46 |
| Packaging issue |
43 |
| Dissection |
42 |
| Device damaged prior to use |
41 |
| Source, detachment from |
40 |
| Balloon pinhole |
39 |
| Hole in material |
34 |
| Tears, rips, holes in device, device material |
34 |
| Difficult to insert |
26 |
| Material perforation |
24 |
| Difficult to position |
23 |
| Device, or device fragments remain in patient |
23 |
| Improper or incorrect procedure or method |
23 |
| Sticking |
23 |
| Foreign material |
22 |
| Material separation |
21 |
| Difficult to advance |
19 |
| Unsealed device packaging |
17 |
| Device markings issue |
16 |
| Markings unclear |
13 |
| Torn material |
12 |
| Not Applicable |
12 |
| Device or device fragments location unknown |
12 |
| Bent |
11 |
| Stretched |
11 |
| Device remains implanted |
10 |
| Crack |
10 |
| Device packaging compromised |
8 |
| Slippage of device or device component |
8 |
| Material puncture |
7 |
| Tip breakage |
7 |
| Tear, rip or hole in device packaging |
6 |
| Malposition of device |
6 |
| Catheter withdrawal interference |
5 |
| Unintended movement |
5 |
| Sterility |
5 |
| No Information |
5 |
| Device Difficult to Setup or Prepare |
4 |
| Device, removal of (non-implant) |
4 |
| Occlusion within device |
4 |
| Size incorrect for patient |
4 |
| Defective item |
4 |
| Material fragmentation |
4 |
| Material deformation |
4 |
| Device expiration issue |
4 |
| Folded |
3 |
| Mislabeled |
3 |
| No code available |
3 |
| Component missing |
3 |
| Incomplete or missing packaging |
3 |
| Incorrect measurement |
3 |
| Dislodged or dislocated |
3 |
| Contamination during use |
3 |
| Delivered as unsterile product |
3 |
| Failure to flush |
2 |
| Out-of-box failure |
2 |
| Implant, removal of |
2 |
| Component(s), broken |
2 |
| Air leak |
2 |
| Unraveled material |
2 |
| Blockage within device or device component |
2 |
| Positioning Issue |
2 |
| Product quality issue |
2 |
| Method, improper/incorrect |
2 |
| Resistance, inadequate |
2 |
| Channeling |
1 |
| Malfunction |
1 |
| Tracking |
1 |
| Failure to pump |
1 |
| Failure to deploy |
1 |
| Dissatisfaction |
1 |
| Pyrogenic |
1 |
| Failure to deliver |
1 |
| Collapse |
1 |
| Bubble(s) |
1 |
| Peeled |
1 |
| Dislodged |
1 |
| Total Device Problems |
6916 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
3 |
1 |
0 |
0 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
