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 2019-02-14 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[136608323]
The impella rp was returned for analysis. The data logs from the case were not. The deformation of the rp was most likely created by the force exerted by the physician in the attempted placement of the rp. The force was due to the difficult insertion into the vasculature and over the guidewire, which had slack. The root cause for the rp pump separation was force applied to the outflow cage struts and welds during the difficult delivery. The failure mode will be monitored and trended.
Patient Sequence No: 1, Text Type: N, H10
[136608324]
An (b)(6) year old male was having coronary artery bypass surgery, and had decompensated when he was taken off surgical bypass. The patient's right ventricle was failing, and so the team placed with difficulty a swan and then attempted to insert the impella rp. The team attempted multiple times and in different orientations to place the rp. Upon removal of the rp, to try placement of a new rp catheter, the team noted the rp had become fractured. The team snared the part of the rp that had detached. After removal of the fractured rp, a new rp catheter was placed successfully via the same access at the right femoral vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2019-00021 |
| MDR Report Key | 8339934 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-14 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2018-12-12 |
| Date Added to Maude | 2019-02-14 |
| 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 | 2019-02-14 |
| Returned To Mfg | 2019-01-28 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1379927 |
| 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 | 2019-02-14 |