MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for IMPELLA CP PUMP IMPELLA CP PUMP SET, JAPAN 0048-0034-JP manufactured by Abiomed, Inc..
[180635762]
The impella cp was discarded by the customer and therefore, investigation of device was not possible. Should any new information be returned, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[180635763]
The complainant reported an (b)(6)-year-old (b)(6) male patient had impella cp pump inserted in the left femoral for acute myocardial infarction and cardiogenic shock (ami/cgs). It was reported that findings from a transthoracic echocardiogram (tte) showed a rupture within the heart. The physician suspected the patient had developed a heart tamponade. An echocardiogram (echo) showed blood was stored in the pericardium. The inlet part of impella was in the pericardium and the outlet was in the left ventricle. The physician was unsure whether the impella had penetrated the left ventricular wall or whether it had moved forward due to a rupture of the left ventricle. Soon after the patient was moved to the incentive care unit and expired. Per the physician the cause of death was due to heart rupture. It is unclear whether it was related to impella.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00351 |
| MDR Report Key | 9746876 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-31 |
| Date Facility Aware | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-12-11 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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, INC. |
| Manufacturer Street | 22 CHERRY HILL DR |
| 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 CP PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-02-24 |
| Model Number | IMPELLA CP PUMP SET, JAPAN |
| Catalog Number | 0048-0034-JP |
| Lot Number | 1450243 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-24 |