MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for IMPELLA CP SET 14F 0048-0003 manufactured by Abiomed, Inc.
[64166978]
Patient Sequence No: 1, Text Type: N, H10
[64166979]
Patient in cardiogenic shock. Dr placed abiomed impella cp catheter. After pump was started, low purge pressure was noted. The impella rep noticed a leak in the catheter housing which is located outside the body. Impella catheter was replaced with a new impella sheath and catheter. At the end of procedure, patient developed a hematoma at the right femoral sheath site. Manual pressure was held and then femstop applied. Patient is still in hospital. The current medical regimen is effective. He is hemodynamically stable and free of bedside evidence of chf except for his trace leg edema. Additionally, he has nothing to suggest any angina and his blood pressure is well controlled. His platelets are coming down, likely a heparin effect; dr will change this to argatroban. Otherwise, continue present medications. Perhaps he can be weaned off impella in am. Device was given to the rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6232975 |
| MDR Report Key | 6232975 |
| Date Received | 2017-01-09 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-14 |
| Report Date | 2016-12-19 |
| Date Reported to FDA | 2016-12-19 |
| Date Reported to Mfgr | 2016-12-19 |
| Date Added to Maude | 2017-01-09 |
| 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 SET |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2017-01-09 |
| Returned To Mfg | 2016-12-15 |
| Model Number | 14F |
| Catalog Number | 0048-0003 |
| Lot Number | 21 109432 17 180630 |
| ID Number | 0048-2604/B |
| Device Expiration Date | 2018-06-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-01-09 |