MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for IMPELLA CP manufactured by Abiomed, Inc..
[53332816]
Patient Sequence No: 1, Text Type: N, H10
[53332817]
In the cath lab, an impella device was placed in the right groin. Although sedated, the patient became agitated and thrashed his leg. The device at that point began to alarm and it was found to be kinked in the patient. Upon trying to remove the device, the device broke at the point of the kink and remained in his body. The broken piece was able to be removed completely with snare. Post fluoroscopy showed no retained pieces and no lacerations or punctures from the device. The patient tolerated the incident well and a new device was successfully placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5909835 |
| MDR Report Key | 5909835 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-23 |
| Report Date | 2016-08-25 |
| Date Reported to FDA | 2016-08-25 |
| Date Reported to Mfgr | 2016-08-25 |
| Date Added to Maude | 2016-08-29 |
| 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 |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-08-29 |
| Operator | PHYSICIAN |
| 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 | 2016-08-29 |