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 2020-02-21 for IMPELLA CP PUMP IMPELLA CP PUMP SET EU 0048-0002 manufactured by Abiomed Europe Gmbh.
[182036447]
The device was not returned by the customer. The 13fr sheath was not returned by the customer therefore a failure analysis investigation cannot be completed. If device is received after this date, an evaluation will be performed and a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182036448]
The complainant reported a female patient with cardiogenic shock (cgs). The physician tried to access with two (2) different 14fr sheaths and one (1) 13fr sheath but failed to be introduced into the vessel. The sheath? Splitted? At the tip and rolled up so they were broken. This patient is obese and the arterial femoral was? Deep? Under the tissue, there was groin bleedings after several punctures. The bleedings was intervened by an angiologist with a covered stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00347 |
| MDR Report Key | 9742057 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-24 |
| Date Facility Aware | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-02-21 |
| 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 EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| 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, OZD |
| Product Code | OZD |
| Date Received | 2020-02-21 |
| Model Number | IMPELLA CP PUMP SET EU |
| Catalog Number | 0048-0002 |
| Lot Number | 1449532 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074 GM 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |