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 2018-12-31 for IMPELLA RP 004334 manufactured by Abiomed, Inc..
[131741644]
The impella rp 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
[131741645]
A complainant reported a (b)(6) year old male presenting with right ventricular failure. An impella rp was inserted without issue. During procedure, insertion site was found bleeding. As treatment, 1 unit of blood products were administered and bleed has since resolved. Patient continued to receive treatment with this device and has since been weaned successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00175 |
| MDR Report Key | 8206914 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-12-31 |
| Date of Report | 2019-02-07 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2018-12-31 |
| 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 RP |
| Generic Name | TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-12-31 |
| Returned To Mfg | 2018-12-26 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1321488 |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-31 |