MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-19 for THORATEC CORPORATION manufactured by St. Jude Medical.
[100530482]
On (b)(6) 2018, pt was at therapy and while going to the bathroom, his driveline "got tugged". His driveline anchor was not secured properly. After pt felt the "tug" his controller started alarming. He examined his driveline and noticed a crack approx 1 inch from his skin. Pt states he then took his driveline in his hand, and bent it all the way in half at the fracture site, so he could clearly see what was wrong with it. At this time the vad stopped functioning. Pt reported chest discomfort and was transferred to (b)(6). He was started on epinephrine and milrinone. The thoratec engineer team was contacted and stated that currently there is no fda approved correction to this driveline. On (b)(6) 2018, pt was taken to the operating room for a hm3 pump exchange that was complicated by post operative bleeding. He went back to the operating room for chest exploration on (b)(6) 2018 d/t bleeding and source of bleeding was fixed. He continued to progress and was discharged home on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7282892 |
| MDR Report Key | 7282892 |
| Date Received | 2018-02-19 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-26 |
| Date Facility Aware | 2018-01-26 |
| Report Date | 2018-02-16 |
| Date Reported to FDA | 2018-02-16 |
| Date Added to Maude | 2018-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THORATEC CORPORATION |
| Generic Name | HEARTMATE III |
| Product Code | OKR |
| Date Received | 2018-02-19 |
| Returned To Mfg | 2018-01-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 6035 STONERIDGE DR PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-02-19 |