MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for IMPELLA 129265 00480003 manufactured by Abiomed.
[88863425]
Patient Sequence No: 1, Text Type: N, H10
[88863426]
The patient required placement of an impella ventricular assist device via left common femoral introducer sheath. The device became entrapped on attempt at removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6935619 |
| MDR Report Key | 6935619 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-08-29 |
| Report Date | 2017-09-06 |
| Date Reported to FDA | 2017-09-06 |
| Date Reported to Mfgr | 2017-09-06 |
| Date Added to Maude | 2017-10-10 |
| 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 |
| 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 |
| Generic Name | IMPELLA LEFT VENTRICULAR ASSIST DEVICE |
| Product Code | OJE |
| Date Received | 2017-10-10 |
| Model Number | 129265 |
| Catalog Number | 00480003 |
| Device Expiration Date | 2019-04-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-10 |