FDA Adverse Event
Death
Summary report: N
LARIAT SUTURE DELIVERY DEVICE
MDR report key: 3374504
·
Received September 20, 2013
Report
- Report Number
- 3005802238-2013-00010
- Event Type
- Death
- Date Received
- September 20, 2013
- Date of Event
- August 23, 2013
- Manufacturer
- SENTREHEART, INC.
- Product Code
- GAT
- PMA / PMN Number
- K090385
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE. AFTER TIGHTENING OF THE LARIAT, BLEEDING OCCURRED AND A SIGNIFICANT EFFUSION DEVELOPED. THE LARIAT WAS REMOVED FROM THE PT AND THE PT WAS CONVERTED TO SURGERY. THE SURGEON WAS ABLE TO STOP THE BLEEDING AND THE PT REMAINED IN THE HOSPITAL. WE WERE SUBSEQUENTLY NOTIFIED THAT THE PT EXPIRED 2 DAYS LATER. NO AUTOPSY WAS PERFORMED, BUT CAUSE OF DEATH PER THE PHYSICIAN WAS PEA (PULSELESS ELECTRICAL ACTIVITY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475713 | LARIAT SUTURE DELIVERY DEVICE | REMOTE SUTURE DELIVERY DEVICE | GAT | SENTREHEART, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death| R |