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 2020-02-26 for IMPELLA CP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed Inc..
[182037825]
To date the medical facility has not yet returned any impella product for analysis. When the investigation is completed a final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182037826]
A patient admitted with a complex medical history was admitted to the medical facility with difficulty breathing. After a right heart catheterization was performed, the team chose to place an impella cp for hemodynamic support. After insertion a hematoma developed at the access site. The hematoma was treated by femostop compression. The patient was bleeding from the access site for the swan as well. Due to the blood loss the team infused blood product. After 54 hours of support the team chose to explant the impella. Shortly after explant the patient experienced signs of limb ischemia. There was discussion of possible amputation, but this was not done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00354 |
| MDR Report Key | 9758831 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-31 |
| Date Facility Aware | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2020-01-08 |
| Date Added to Maude | 2020-02-26 |
| 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 DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461400 |
| Manufacturer G1 | ABIOMED INC. |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| 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 NONROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-02-26 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0024 |
| Lot Number | 1454868 |
| 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 INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-26 |