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 2018-08-23 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[118112963]
The impella rp was returned to the manufacturer for evaluation. During the visual examination of the returned pump, deformation and damage was found at the struts of the outflow cage, suggesting that a radically compressive force was applied to the struts at some point during the set-up and delivery of the pump to the pa. The cause of this load is unknown, but may have resulted from the tortuosity of the path from the femoral vein to the ivc. Left femoral insertion is cautioned against in the impella rp's instructions for use. A review of the device history records for this device revealed that there had been no manufacturing issues for this pump related to this failure mode. There have been no other complaints for other pumps in this lot relevant to this failure mode.
Patient Sequence No: 1, Text Type: N, H10
[118112964]
The complainant reported that on (b)(6) 2018 the physician was attempting to place an impella rp in the left femoral artery of a (b)(6) female patient. It was reported that when the impella's distal tip reached the poster anterior pulmonary artery the clinician noticed that the outflow cage and the pigtail were separated from the impella cannula. The remaining portion of the impella rp cannula was removed through the sheath, a snare was employed to pull the remaining outflow cage and pigtail through the sheath. Another impella rp a used and that device was easily inserted without complication. The complainant reported that the patient was successfully supported with the second impella rp that was placed, and that there were no adverse effects to the patient as a result of the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00087 |
| MDR Report Key | 7810929 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-23 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2018-08-23 |
| 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 G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN, 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| 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 | 2018-08-23 |
| Returned To Mfg | 2018-07-27 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1293940 |
| Device Expiration Date | 2019-06-30 |
| 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 | 2018-08-23 |