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 2018-10-30 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[125476424]
The product and data logs have been returned for analysis. The investigation is on-going at this time. A supplemental will be drafted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[125476425]
A (b)(6) patient in cardiogenic shock and an acute myocardial infarction, was brought to the cardiac cath lab for placement of the impella 2. 5, without a representative from abiomed on site. Some time later, the physician removed the impella as it had come out of the left ventricle due to an unknown cause. When the physician placed a second impella, the pump placed to the left ventricle was not another 2. 5, a left sided pump, but rather the right heart sided, rp device. The team noticed this after the pump was running, removed the pump, and began cpr. The patient did expire despite efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00131 |
| MDR Report Key | 8019281 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2017-09-21 |
| Date Added to Maude | 2018-10-30 |
| 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 | 2018-10-30 |
| Returned To Mfg | 2018-10-10 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1301319 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| 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. Life Threatening; 3. Required No Informationntervention | 2018-10-30 |