MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for IMPELLA CP 0048-0003.0814 0048-0003 manufactured by Abiomed, Inc..
[103017260]
Patient Sequence No: 1, Text Type: N, H10
[103017261]
The impella cp catheter failed while implanted in patient. The flow started out between 3. 2 and 3. 4 and then dropped to 1. 2. The catheter was removed, flushed out, and re-implanted, but flow never went above 1. 2. It was eventually replaced with a 2. 5 l pump that was not sufficient to support the patient. A right axillary cutdown was performed and 5l pump was place. Although unrelated to the pump failure, the patient expired in the operating room. Per site reporter: (b)(4) reps were present during surgery. The device will be returned for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7356683 |
| MDR Report Key | 7356683 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-03-08 |
| Report Date | 2018-03-15 |
| Date Reported to FDA | 2018-03-15 |
| Date Reported to Mfgr | 2018-03-15 |
| Date Added to Maude | 2018-03-21 |
| 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 CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2018-03-21 |
| Model Number | 0048-0003.0814 |
| Catalog Number | 0048-0003 |
| Device Expiration Date | 2019-12-31 |
| Device Availability | Y |
| Device Age | 0 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 | 1. Other | 2018-03-21 |