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 2018-02-02 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[99099189]
For the failure analysis both the introducer product and data logs were returned. The investigation is on-going at this time. A supplemental medwatch will be submitted at conclusion of the investigation. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[99099190]
A (b)(6) male was admitted for a bypass surgery (cabg) in which five grafts were to be placed. After the cabg an impella rp was placed for patient support. While placing the rp the team kinked two 23fr x 30 cm introducers. The third introducer allowed for successful placement. The rp was being used in addition to an already placed iabp, which was also placed at the right femoral/groin access site. The patient developed a hematoma at the right groin on the following day due to bleeding. The team administered an estimated 20 units of blood product, and three additional purse string sutures were placed at the rp access site in the operating room, to control the access site bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00003 |
| MDR Report Key | 7238301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-02 |
| Date of Report | 2018-01-12 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-01-12 |
| Device Manufacturer Date | 2017-02-10 |
| Date Added to Maude | 2018-02-02 |
| 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 MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461400 |
| Manufacturer G1 | ABIOMED |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | TEMPORARY RIGHT HEART SUPPOR BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-02-02 |
| Returned To Mfg | 2018-01-25 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1269486 |
| Device Expiration Date | 2018-10-31 |
| 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 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-02 |