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 2019-01-25 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[134182230]
For the investigation the rp pump was returned for analysis, though it was returned cut by the user. The pump was returned for review with both the catheter and repositioning unit cut. The introducer was not returned for analysis. No damage was observed to the returned portion of the device, the root cause of the access site bleed was unable to be determined without the complete product. Should the introducer be returned for analysis, a supplemental medwatch will be completed inclusive of any new findings.
Patient Sequence No: 1, Text Type: N, H10
[134182231]
A patient was placed on the impella rp for support due to right heart failure post-pulmonary embolism. After eleven hours of support, the team removed the rp due to a venous access site bleed, which troubleshooting in the form of both the placement of a femostop and stitch failed. The team infused units of blood product back to the patient. It is unknown if the blood infusion was 1 or 2 units.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2019-00004 |
| MDR Report Key | 8279477 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-25 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-12-28 |
| Date Mfgr Received | 2018-12-28 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2019-01-25 |
| 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 NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2019-01-25 |
| Returned To Mfg | 2019-01-09 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1323607 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-25 |