MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-21 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[100560510]
The impella rp was returned for evaluation, although the introducer used during this event was discarded by the user. The evaluation of the returned pump has not yet been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100560611]
The patient was brought to the cardiac care lab, where a swan-ganz was placed in the rca. A balloon tipped pulmonary artery catheter was placed in the left pulmonary artery. The physician was unable to advance the impella rp and lost wire placement. The pump was backed out, and a portion of the sheath was noted in the cannula of the rp and was exiting through the cannula cage. A new impella rp was obtained and the sheath was exchanged with a new 23fr peel-away sheath. Approximately 20 cc's of blood was lost at the femoral vein access site, but did not require any replacement blood products to be administered. The patient was supported with the replacement impella rp for 7. 92 hours, when he began to decompensate and was severely anemic and acidotic. The family decided to withdraw care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00010 |
| MDR Report Key | 7285565 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-21 |
| Date of Report | 2018-01-26 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-03-06 |
| Device Manufacturer Date | 2017-07-07 |
| Date Added to Maude | 2018-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9788828068 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074, GM, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2018-02-21 |
| Returned To Mfg | 2018-02-15 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1296280 |
| Device Expiration Date | 2019-06-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074, GM, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-21 |