MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for IMPELLA IMPELLA CP PUMP SET 0048-0003.0814 manufactured by Abiomed, Inc..
[182762692]
Occluded left common femoral artery at site of impella insertion during pci.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9811348 |
| MDR Report Key | 9811348 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-11-06 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-03-10 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| 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 |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2020-03-10 |
| Model Number | IMPELLA CP PUMP SET |
| Catalog Number | 0048-0003.0814 |
| Device Availability | N |
| 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 | 1. Other | 2020-03-10 |