MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for HEARTMATE 3 LVAS IMPLANT KIT 106524US manufactured by Thoratec Corporation.
[186592060]
No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[186592061]
The patient's pump would not engage mini apical cuff. The surgeon and clinical specialist that the purple locking mechanism would completely lock into place without being secured to an apical cuff and that the prongs of the locking mechanism that slide against the inflow cannula were not sliding symmetrically (with one of them not coming into contact with side of the inflow cannula at all). The locking mechanism did not function as intended and should not be locked while connected to an apical cuff when sliding in and out. The pump was determined to be not functioning as intended and unsafe. The pump was explanted and a new hm3 pump was implanted into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01765 |
| MDR Report Key | 9899342 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-12-06 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE 3 LVAS IMPLANT KIT |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-30 |
| Model Number | 106524US |
| Catalog Number | 106524US |
| Lot Number | 7302761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |