| Device |
device, hemostasis, vascular |
| Product Code | MGB |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
18
|
20
|
34
|
22
|
23
|
16
|
7
|
|
| Device Problems |
| Difficult to remove |
1256 |
| Couple, failure to |
1164 |
| Device operates differently than expected |
1126 |
| Failure to deploy |
1122 |
| Unknown (for use when the device problem is not known) |
785 |
| Source, detachment from |
441 |
| Improper or incorrect procedure or method |
361 |
| Mislocation |
321 |
| Use of Device Issue |
318 |
| Difficult to deploy |
266 |
| Detachment of device component |
244 |
| Retraction problem |
215 |
| Break |
198 |
| Other (for use when an appropriate device code cannot be identified) |
169 |
| No Known Device Problem |
152 |
| Method, improper/incorrect |
142 |
| Resistance, loss of |
103 |
| Difficult to insert |
97 |
| Collapse |
91 |
| Difficult to position |
88 |
| Bent |
81 |
| Physical resistance |
78 |
| Blockage within device or device component |
69 |
| Loose |
42 |
| Kinked |
38 |
| No Information |
29 |
| Leak |
25 |
| Premature deployment |
25 |
| Failure to advance |
23 |
| Failure to cut |
18 |
| Device, removal of (non-implant) |
17 |
| Inaccurate delivery |
12 |
| Torn material |
11 |
| Component missing |
11 |
| Device Issue |
10 |
| Stretched |
8 |
| Device damaged prior to use |
7 |
| Physical property issue |
6 |
| Foreign material present in device |
6 |
| Migration of device or device component |
6 |
| Twisting |
4 |
| Misplacement |
4 |
| Tears, rips, holes in device, device material |
4 |
| Material deformation |
4 |
| Deflation issue |
3 |
| Packaging issue |
3 |
| Device expiration issue |
3 |
| Dislodged |
2 |
| Loose or intermittent connection |
2 |
| Sticking |
2 |
| Seal, defective |
2 |
| Failure to separate |
2 |
| Failure to deliver |
2 |
| Device, or device fragments remain in patient |
2 |
| Material twisted |
2 |
| Malfunction |
2 |
| Noise |
2 |
| Defective item |
2 |
| Material perforation |
2 |
| Tip breakage |
2 |
| Deployment issue |
2 |
| Seal, incorrect |
2 |
| Failure to align |
1 |
| Size incorrect for patient |
1 |
| Tear, rip or hole in device packaging |
1 |
| Syringe, defective |
1 |
| Material rupture |
1 |
| Device remains implanted |
1 |
| Occlusion within device |
1 |
| Misassembled |
1 |
| Entrapment of device or device component |
1 |
| Delivered as unsterile product |
1 |
| Difficult or delayed activation |
1 |
| Shaft, split |
1 |
| Device or device component damaged by another device |
1 |
| Fracture |
1 |
| Displacement |
1 |
| Coiled |
1 |
| Material fragmentation |
1 |
| Balloon leak(s) |
1 |
| Incorrect display |
1 |
| Plunger Issue, No Description |
1 |
| Device misassembled during manufacturing or shipping |
1 |
| Reverse osmosis |
1 |
| Disengaged |
1 |
| Out-of-box failure |
1 |
| Alarm, no lead |
1 |
| Clips, scissored |
1 |
| Inadequate training |
1 |
| Suture line separation |
1 |
| Total Device Problems |
9264 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
