MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for IMPELLA CP SET 0048-0003 manufactured by Abiomed, Inc..
[182151697]
0. 018 impella wire unwound and fractured in the patient. The entire wire was retrieved and there was no evidence of any retained wire in the patient. A new wire was obtained from another kit and the case continued. Impella wire advanced through pigtail catheter. Pigtail removed. Impella catheter advanced over the wire to lv, wire removed. Wire fragment noticed on x-ray in impella. Impella catheter and wire removed. 6fr. Pigtail advanced over the wire to lv, wire removed. Impella wire advanced through pigtail catheter. Pigtail removed. Impella catheter advanced over the wire to lv, wire removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9792497 |
| MDR Report Key | 9792497 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-11-25 |
| Report Date | 2020-01-16 |
| Date Reported to FDA | 2020-01-16 |
| Date Reported to Mfgr | 2020-03-05 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA CP SET |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2020-03-05 |
| Catalog Number | 0048-0003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-05 |