BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP

    MDR report key: 12921254 · Received December 2, 2021

    Report

    Report Number
    3011706110-2021-00052
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    October 21, 2020
    Report Date
    December 2, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    PMA / PMN Number
    K191413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CASE- (B)(4). THE PRO V50 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 102939. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A STAGED CONVERGENT PROCEDURE WITH LEFT ATRIAL APPENDAGE (LAA) EXCLUSION. THE PATIENT'S LAA HAD ADHESIONS THAT MADE CLIP PLACEMENT AT THE BASE DIFFICULT. THE PROV50 CLIP WAS PLACED LEAVING AN ESTIMATED RESIDUAL STUMP OF >1 CM. A CT SCAN 2 MONTHS AFTER THE EPICARDIAL PROCEDURE IN PREPARATION FOR THE ENDOCARDIAL PORTION OF THE CONVERGENT PROCEDURE, THERE WAS AN OBSERVED RESIDUAL STUMP OF APPROXIMATELY 3 CM. THE PATIENT RECEIVED AN ENDOCARDIAL IMPLANT FOR LEFT ATRIAL APPENDAGE MANAGEMENT. THERE WAS NO ADVERSE PATIENT AFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819728 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP PZX ATRICURE, INC. PRO V50 102939

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male