MalfunctionPZX
ATRICLIP® LAA EXCLUSION SYSTEM
Received Dec 30, 2022 · Event occurred Nov 14, 2022
Report 16077187 · MDR key 16077187
Device
Generic name
Left Atrial Appendage Clip, Implantable
Manufacturer
Atricure, Inc.Model number
PRO240Catalog number
A000966
Lot number
111774
Product problems
- Mechanical Jam
Patient
29565 DA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SIZE 40 ATRICLIP PRO2 OPENED FOR LEFT VATS/ATRIAL APPENDAGE CLIPPING. DEVICE WAS FROM ATRICURE REP STOCK. DEVICE JAMMED BUT BEFORE USING ON PATIENT. ATRICURE REPS IN THE ROOM AND DEVICE WAS SEQUESTERED AND SAVED BY DEVICE REPS SO THEY CAN RUN A DIAGNOSTIC REPORT ON IT.