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 2020-03-18 for IMPELLA CP IMPELLA CP C7 W V3 GWRU SET, US 0048-0032 manufactured by Abiomed, Inc..
[184046466]
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
[184046467]
The complainant reported a (b)(6) white male patient presenting with acute myocardial infarction and cardiogenic shock for hemodynamic support using the impella cp pump. The physician reported pump not properly positioning within the ventricle, therefore, an attempt was made to remove and re-insert the device. During attempted removal, the device failed to exit the introducer due to looping of the guidewire. The introducer, pump, and guidewire were removed as one unit and a new pump was inserted, however, the patient developed a hematoma at the pump's insertion site. After patient's hemodynamics stabilized with the second pump, surgical removal was performed. Surgical removal was required due to hematoma that afflicted the insertion site from the pump in question.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00386 |
| MDR Report Key | 9849464 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-20 |
| Date Facility Aware | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-18 |
| Model Number | IMPELLA CP C7 W V3 GWRU SET, US |
| Catalog Number | 0048-0032 |
| Lot Number | 1436531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-18 |