MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-06 for 684114 manufactured by Ev3.
[1189750]
The patient was brought through the ed. A head ct scan was performed and interventional coiling was attempted. During the procedure, after deploying coils, dr tried to access the pca vessel to try and place a stent across the aneurysm, but was unsuccessful. He then inserted an occlusion balloon (hyperform occlusion balloon system lot# 684114 made by ev3: 7mm balloon diameter, 7mm balloon length. Dr was able to inflate the balloon and was unsuccessful deflating the balloon. Eventually, while trying to remove/deflate the balloon, the balloon ruptured and separated from its catheter. The aneurysm re-ruptured. Pt ctb at 1035 in 2009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012316 |
| MDR Report Key | 1436247 |
| Date Received | 2009-08-06 |
| Date of Report | 2009-08-06 |
| Date of Event | 2009-08-05 |
| Date Added to Maude | 2009-08-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | HYPERFOAM OCCLUSION BALLOON SYSTEM |
| Product Code | MZQ |
| Date Received | 2009-08-06 |
| Model Number | 684114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EV3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-08-06 |