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 2020-03-04 for IMPELLA CP IMPELLA CP C7 W V3 GWRU SET, US 0048-0032 manufactured by Abiomed, Inc..
[182003492]
The impella cp and data logs were returned for evaluation. The device was visually inspected and noted to have fractured impeller blades. Simulated use testing in a basin of water successfully reproduced low pump flows reported. Follow up with the clinical account indicated no other devices were in use within the patients heart. We could not definitively determine the cause of the damaged impeller blades. A review of the dhr was conducted and found no manufacturing issues or reworks associated with this pump lot. There are no other complaints related to this failure mode associated with pumps in this lot.
Patient Sequence No: 1, Text Type: N, H10
[182003493]
The complainant reported a (b)(6) old white male patient presenting for high risk percutaneous coronary intervention using the impella cp pump for hemodynamic support. The pump was inserted without any reported issue, however, flows dropped from 3. 6 l/min to 0. 5 l/min after initiation. Normal troubleshooting attempts did not resolve the issue, therefore, the device was removed and replaced with a second impella pump. Hemodynamic support was successfully achieved, thereafter. On 2020-02-05, upon investigation of the returned device, we identified broken impeller blades.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00360 |
| MDR Report Key | 9787675 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-05 |
| Date Facility Aware | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-10-31 |
| 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 |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2019-12-30 |
| Model Number | IMPELLA CP C7 W V3 GWRU SET, US |
| Catalog Number | 0048-0032 |
| Lot Number | 1442376 |
| 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 | 2020-03-04 |