FDA Adverse Event
Injury
Summary report: N
LARIAT SUTURE DELIVERY DEVICE
MDR report key: 3799461
·
Received April 24, 2014
Report
- Report Number
- 3005802238-2014-00005
- Event Type
- Injury
- Date Received
- April 24, 2014
- Date of Event
- February 27, 2014
- Report Date
- March 26, 2014
- 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
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.
Description of Event or Problem · 1
THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE. UPON REMOVAL OF THE LARIAT AFTER LAA CAPTURE, THE PT'S BLOOD PRESSURE BEGAN TO DROP AND BLOOD FLOW FOLLOWED. AN EFFUSION HAD DEVELOPED AFTER MULTIPLE ATTEMPTS TO CAPTURE THE LAA DUE TO SUBOPTIMAL TEE IMAGING. A DRAIN WAS IMMEDIATELY AND SUCCESSFULLY PLACED TO MANAGE THE EFFUSION. THE PHYSICIAN DECIDED TO SEND THE PT TO SURGERY WHERE THE BLEEDING WAS RESOLVED. PER THE PHYSICIAN, THE PT WAS DOING WELL POST-SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248870 | LARIAT SUTURE DELIVERY DEVICE | REMOTE SUTURE DELIVERY DEVICE | GAT | SENTREHEART INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |