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 2018-04-27 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[106732058]
The impella rp and peel-away sheaths have not yet been returned for evaluation. At this time there is no definitive information indicating that the inability to place the impella rp was the result of any issue with the device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106732059]
The complainant reported that (b)(6) year old female patient was in a slowly decompensating condition, and was in right hear failure. A swan was placed in the patient via the right femoral vein, but there was some initial difficulty experienced by the physician when placing the swan into the left pulmonary artery (lpa). The physician then attempted to place an impella rp. When advancing the pump over the wire the device would not make the turn into the pulmonary artery (pa). An 0. 035 amplatz wire was placed as a buddy wire, but this was not successful in making the turn into the pa. During the 35 minute attempt to place the impella rp, patient bleeding occurred from the peel-away sheath valve. Two units of replacement blood was administered to the patient as a result of the pressures dropping. The sheath was exchanged for another rp peel-way sheath, but the same issue occurred, and the pump would not make the turn into the pa. It was decided to abort the impella rp placement, as a result of the patient's cardiac anatomy. The physician then placed a tandem heart in the patient via the right internal jugular.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00027 |
| MDR Report Key | 7468267 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-27 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2016-09-19 |
| Date Added to Maude | 2018-04-27 |
| 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 | 2018-04-27 |
| Returned To Mfg | 2018-05-02 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1250295 |
| Device Expiration Date | 2018-03-31 |
| 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, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-27 |