MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-08 for IMPELLA CP manufactured by Abiomed, Inc..
[46818470]
Patient Sequence No: 1, Text Type: N, H10
[46818471]
This middle-aged male patient arrived to the cath lab for a left heart catheterization, coronary angiography and a left ventriculogram. The patient was transferred from the cath lab to the main or for an emergent cardiac salvage coronary artery bypass x 3. The patient arrived to the operating room with an impella pump. However, during the case, the impella pump did not register like it did in the beginning of the case. There was a question about whether or the impella pump was working correctly. The surgeon then placed a balloon pump in the patient. The patient subsequently expired during the surgery. It is unknown at this time if this event contributed to the patient's outcome. The rep for a biomed was present during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5705333 |
| MDR Report Key | 5705333 |
| Date Received | 2016-06-08 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-05-31 |
| Report Date | 2016-06-06 |
| Date Reported to FDA | 2016-06-06 |
| Date Reported to Mfgr | 2016-06-06 |
| Date Added to Maude | 2016-06-08 |
| 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 |
| 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 CP |
| Generic Name | PUMP, CATHETER BASED |
| Product Code | PBL |
| Date Received | 2016-06-08 |
| ID Number | 4124615077947 |
| Device Availability | Y |
| 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 | 2016-06-08 |