BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 12040633 · Received June 22, 2021

    Report

    Report Number
    3011706110-2021-00032
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    PMA / PMN Number
    K191413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACH235 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 108091. 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) 2021 A PATIENT UNDERWENT A MITRAL VALVE REPAIR ON BYPASS WITH LEFT ATRIAL APPENDAGE MANAGEMENT PROCEDURE. DURING THE ACH235 ATRICLIP PLACEMENT THE CLIP WOULD NOT RELEASE ONCE ALL 4 SUTURES WERE CUT AND THE CLIP WOULD NOT SLIDE FROM THE DEVICE. WHILE THE PHYSICIAN WAS TRYING TO DETACH THE DEVICE OFF THE CLIP, SOME BLEEDING OCCURRED BELOW THE CLIP AT THE BASE OF THE APPENDAGE. PHYSICIAN REPAIRED APPENDAGE WITH AN ENDOCARDIAL SUTURE. THIS WAS A PROCEDURAL RELATED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941660 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP PZX ATRICURE, INC. ACH235 108091

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R