BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP

    MDR report key: 10393695 · Received August 11, 2020

    Report

    Report Number
    3011706110-2020-00022
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 11, 2020
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE (B)(4) - THE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 101849. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICE WAS RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020 A (B)(6) FEMALE PATIENT WITH A HISTORY OF ATRIAL FIB, UNDERWENT A TOTAL THORACOSCOPIC SURGICAL AND LEFT ATRIAL APPENDAGE MANAGEMENT PROCEDURE. PRE-PROCEDURE TEE SHOWED A CLEAR LEFT ATRIAL APPENDAGE. THE PROCEDURE WAS COMPLETED WITH THE RF ABLATION (EML2) AND A PRO245 SUCCESSFULLY PLACED ON THE LAA. THERE WERE NO PROCEDURAL COMPLICATIONS. POST-PROCEDURE SAME DAY, IT WAS NOTED, PATIENT¿S DISTAL ARTERY PULSES WERE NOT PALPABLE IN ONE OF THE LOWER EXTREMITIES, A CLOT WAS IDENTIFIED. PATIENT WAS RETURNED TO OR, AND CLOT WAS REMOVED SUCCESSFULLY, PATIENT IS DOING WELL. PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858000 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE¿ CLIP FZP ATRICURE, INC. PRO245 101849

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R