MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for IMPELLA CP 0048-000 manufactured by Abiomed Inc..
[75852830]
Impella catheter failed during an acute stemi procedure. The catheter functioned properly for 1 hour before an apparent malfunction. When the malfunction occurred, the patient's condition deteriorated quickly requiring intubation and cpr until the impella cp catheter and console could be exchanged for a new impella cp catheter and impella console. The second catheter and console functioned properly and the case was completed without further complications. Impella pump intermittently shut off and turned on, on its own, before complete malfunction. Representative was notified of equipment symptoms prior to failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069951 |
| MDR Report Key | 6585550 |
| Date Received | 2017-05-22 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-17 |
| Date Added to Maude | 2017-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | IMPELLA CP |
| Generic Name | IMPELLA CP |
| Product Code | PBL |
| Date Received | 2017-05-22 |
| Returned To Mfg | 2017-05-17 |
| Model Number | 0048-000 |
| Lot Number | 123319 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-05-22 |