MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-17 for IMPELLA CP PUMP IMPELLA CP PUMP SET EU 0048-0002 manufactured by Abiomed Europe Gmbh.
[183924734]
The impella cp pump was not returned by the customer therefore a failure analysis investigation cannot be completed. If device is received after this date, an evaluation will be performed and a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183924735]
The complainant reported a (b)(6) old white male patient had impella cp pump inserted in the left femoral for acute myocardial infarction (ami) with shock takotsubo <10%. The cannula broke inside the patient? S left ventricle (lv) and as a result a special lasso wire was used to remove the broken cannula. The patient expired due to takotsubo <10% which is unrelated to impella.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00383 |
| MDR Report Key | 9845484 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-02 |
| Date Facility Aware | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2020-01-11 |
| Date Added to Maude | 2020-03-17 |
| 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 DR. |
| 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 CP PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, |
| Product Code | OZD |
| Date Received | 2020-03-17 |
| Model Number | IMPELLA CP PUMP SET EU |
| Catalog Number | 0048-0002 |
| Lot Number | 1455282 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2020-03-17 |