BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS.

    MDR report key: 3131080 · Received May 24, 2013

    Report

    Report Number
    3003502395-2013-00007
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED FAILURE OF THE DEVICE BY MEDICAL PERSONNEL AND THEREFORE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES OR REWORKS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE AFTER THE CLIP WAS PLACED SUCCESSFULLY, THE SURGEON PULLED THE ORANGE TAB AND WAS READY TO REMOVE THE APPLIER FROM THE PATIENT. THE SURGEON PULLED THE RIMMEL THAT WAS HOLDING THE INCISION SITE WHICH ALLOWED AIR TO ENTER INTO THE CHEST CAUSING THE HEART TO JUMP AND THE APPLIER MOVED FURTHER INTO THE CHEST CAVITY. THE SURGEON PULLED TO REMOVE THE APPLIER WHICH HAD APPARENTLY SNARED ONTO THE CLIP AND IN DOING SO, TORE THE LEFT ATRIUM. SEVERE BLEEDING ENSURED AND WAS UNABLE TO BE STOPPED. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230854 ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS. CLIP, IMPLANTABLE FZP ATRICURE, INC. PRO145 42468

    Patients

    Seq Age Sex Outcome Treatment
    1 Death