FDA Adverse Event
Malfunction
Summary report: N
ATRICLIP
MDR report key: 23802504
·
Received December 15, 2025
Report
- Report Number
- 23802504
- Event Type
- Malfunction
- Date Received
- December 15, 2025
- Date of Event
- October 17, 2025
- Report Date
- November 20, 2025
- Manufacturer
- ATRICURE, INC.
- Product Code
- PZX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DEVICE SLIPPED OFF APPENDAGE/ DID NOT CLIP APPENDAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291670 | ATRICLIP | LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE | PZX | ATRICURE, INC. | ACH235 | 150594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |