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 RP IMPELLA RP US PUMP SET 004334 manufactured by Abiomed, Inc..
[182003314]
The 23 fr introducer was retained 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
[182003315]
The complainant reported a (b)(6) old white male patient presenting with acute myocardial infarction and cardiogenic shock for hemodynamic support with the impella rp. Upon insertion of the 23 fr introducer, the tip split and caused a venous tear. As treatment, the introducer was removed, the vein was stented, and a new 23 fr introducer was placed without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00363 |
| MDR Report Key | 9787746 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-07 |
| Date Facility Aware | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-11-21 |
| 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 RP |
| Generic Name | TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP, OZD |
| Product Code | PYX |
| Date Received | 2020-03-04 |
| Model Number | IMPELLA RP US PUMP SET |
| Catalog Number | 004334 |
| Lot Number | 1446362 |
| 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 | 2020-03-04 |