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 2020-03-04 for IMPELLA CP PUMP IMPELLA CP C7 W V3 GWRU SET, US 0048-0032 manufactured by Abiomed, Inc..
[182003138]
The impella cp was returned by the customer and a failure analysis investigation is underway. A supplemental mdr will be filed at the completion of the device's investigation.
Patient Sequence No: 1, Text Type: N, H10
[182003139]
The complainant reported a (b)(6) white male patient had impella cp pump inserted in the right femoral for cardiogenic shock (cgs). The patient? S right leg looked mottled and the decision was made to remove the pump. This patient looked to have peripheral arterial disease (pad). Thrombus was noted in the iliac system and as a result angiovac and balloon angioplasty was done to restore flow. The patient was brought to the operating room (or) for thrombectomy and fasciotomy was needed post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00362 |
| MDR Report Key | 9787739 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-10 |
| Date Facility Aware | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2020-01-29 |
| Date Added to Maude | 2020-03-04 |
| 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, 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 | 2020-03-04 |
| Returned To Mfg | 2020-02-13 |
| Model Number | IMPELLA CP C7 W V3 GWRU SET, US |
| Catalog Number | 0048-0032 |
| Lot Number | 1458877 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2020-03-04 |