BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP

    MDR report key: 10734669 · Received October 26, 2020

    Report

    Report Number
    3011706110-2020-00032
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 26, 2020
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE-(B)(4). THE PRO235 ATRICLIP DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 103803. 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 · 1

    IT WAS REPORTED ON (B)(6) 2020 THAT A PATIENT UNDERWENT A CONVERGENT EPICARDIAL ABLATION AND LEFT ATRIAL APPENDAGE (LAAM) MANAGEMENT PROCEDURE. DURING LAA PORTION OF THE CLIP PLACEMENT PROCEDURE THE ATRICLIP PRO235 WAS UNABLE TO BE DEPLOYED AT THE POSITION THE SURGEON HAD INTENDED. THE SURGEON ATTEMPTED TO PULL THE CLIP OUT AND DURING ATTEMPT TO REMOVE THE CLIP THE DEVICE CAUGHT A CORNER OF THE APPENDAGE CAUSING LAA TEAR AND BLEEDING. THE SURGEON USED SNOW AND FLOSEAL TO STOP BLEEDING AND STABILIZED THE PATIENT. POST-OPERATIVELY THE PATIENT WAS DOING WELL. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198006 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE¿ CLIP FZP ATRICURE, INC. PRO235 103803

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R EPI-SENSE