| Device Problems |
| Migration of device or device component |
190 |
| Detachment of device component |
131 |
| Material perforation |
116 |
| Difficult to remove |
107 |
| Failure to deploy |
106 |
| Difficult to deploy |
104 |
| Occlusion within device |
69 |
| Other (for use when an appropriate device code cannot be identified) |
54 |
| Malposition of device |
49 |
| Premature deployment |
44 |
| Device remains implanted |
40 |
| Filter |
36 |
| No Known Device Problem |
32 |
| Fracture |
32 |
| Twisting |
31 |
| Break |
26 |
| Misplacement |
25 |
| Deployment issue |
21 |
| Detachment of device or device component |
21 |
| Device, or device fragments remain in patient |
20 |
| Material separation |
20 |
| Inaccurate delivery |
17 |
| Implant, removal of |
15 |
| Strut fracture |
12 |
| Unintended movement |
12 |
| Unknown (for use when the device problem is not known) |
11 |
| Dislodged or dislocated |
9 |
| Material puncture |
9 |
| No code available |
7 |
| Filter break(s) |
6 |
| Device Issue |
6 |
| Tears, rips, holes in device, device material |
5 |
| Device, removal of (non-implant) |
5 |
| Packaging issue |
5 |
| Difficult to open or close |
5 |
| Kinked |
5 |
| Extrusion |
5 |
| Difficult to advance |
4 |
| Material frayed |
4 |
| Difficult to insert |
4 |
| Dislodged |
4 |
| Peeled |
3 |
| Improper or incorrect procedure or method |
3 |
| Tear, rip or hole in device packaging |
3 |
| Failure to advance |
3 |
| Bent |
3 |
| Filter, inadequate |
3 |
| Displacement |
3 |
| Material erosion |
3 |
| Delivered as unsterile product |
3 |
| Malfunction |
3 |
| Failure to expand |
3 |
| Impedance issue |
3 |
| Torn material |
3 |
| Failure to deliver |
3 |
| Retraction problem |
3 |
| Explanted |
3 |
| Component(s), broken |
3 |
| Difficult to position |
3 |
| Failure to unfold or unwrap |
2 |
| Use of Device Issue |
2 |
| Defective item |
2 |
| Device or device fragments location unknown |
2 |
| Material rupture |
2 |
| Device operates differently than expected |
2 |
| Device or device component damaged by another device |
2 |
| Difficult to fold or unfold |
2 |
| Foreign material present in device |
2 |
| Failure to Adhere or Bond |
2 |
| Failure to capture |
1 |
| Dome collapse |
1 |
| Performance |
1 |
| Sticking |
1 |
| Tip breakage |
1 |
| Incorrect device or component shipped |
1 |
| Material integrity issue |
1 |
| Leak |
1 |
| Physical resistance |
1 |
| Delivery System Issue, No Description |
1 |
| Out-of-box failure |
1 |
| Sterility |
1 |
| Device clogged |
1 |
| Continuous mode failure |
1 |
| Material disintegration |
1 |
| Filter, assembly |
1 |
| Material fragmentation |
1 |
| Handpiece detachment |
1 |
| Device damaged prior to use |
1 |
| Underdelivery |
1 |
| Output above specifications |
1 |
| Percutaneous |
1 |
| Disconnection |
1 |
| Unfold, difficult to |
1 |
| Connection issue |
1 |
| Device disinfection or sterilization issue |
1 |
| Obstruction within device |
1 |
| Fluid leak |
1 |
| Instruction for use issue |
1 |
| Device abrasion from instrument or another object |
1 |
| Deflation issue |
1 |
| Total Device Problems |
1529 |
