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 2020-03-26 for IMPELLA CP OPTICAL PUMP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed, Inc..
[185477403]
Device discarded by customer. The impella cp optical pump was discarded by the customer therefore a failure analysis investigation cannot be completed.
Patient Sequence No: 1, Text Type: N, H10
[185477404]
The complainant reported a (b)(6) white male patient had impella cp optical pump inserted in the left femoral artery (lfa) for acute myocardial infarction (ami)/ cardiogenic shock (cgs). Upon removal of the peel-away sheath post procedure, it was noted that the lfa site was bleeding and despite attempts to angle match the catheter and "snug" the perclose sutures around the sheath the site continued to bleed. The physician decided to remove the pump and obtain hemostasis on the lfa site with perclose. A second pump was placed due to hemodynamic instability. A central line was placed for blood/fluids to be administered. The patient was initially given two (2) units of whole blood and three (3) more units of whole blood was giving during the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00395 |
| MDR Report Key | 9887049 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-06 |
| Date Facility Aware | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2020-02-05 |
| Date Added to Maude | 2020-03-26 |
| 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 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 OPTICAL PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, |
| Product Code | OZD |
| Date Received | 2020-03-26 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0024 |
| Lot Number | 1460151 |
| 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 | 2020-03-26 |