MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for IMPELLA CP 0048-0003 manufactured by Abiomed, Inc..
[42410836]
Patient Sequence No: 1, Text Type: N, H10
[42410837]
Impella device fractured during deployment. Device was placed through a edwards 14f/35cm sheath. The typical sheath utilized 14f/30 cm cook was out of stock. Device did kink after being placed into and out rv multiple times. This repositioning was necessary because of incessant vt episodes. Fractured device was retrieved utilizing 2 snares. A new device was successfully placed through a 16f/30 cook sheath. This resulted in 2 hours of additional case time. Patient was returned to the icu after successful coronary artery intervention in critical condition. Lack of standard sheath (14f/30cm cook) and frequent repositioning of catheter were factors that contributed to this fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5569462 |
| MDR Report Key | 5569462 |
| Date Received | 2016-04-12 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-03-30 |
| Report Date | 2016-04-01 |
| Date Reported to FDA | 2016-04-01 |
| Date Reported to Mfgr | 2016-04-01 |
| Date Added to Maude | 2016-04-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA CP |
| Generic Name | BLOOD PUMP, TEMPORARY CARDIAC SUPPORT |
| Product Code | PBL |
| Date Received | 2016-04-12 |
| Catalog Number | 0048-0003 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |