BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6196172 · Received December 21, 2016

    Report

    Report Number
    3003502395-2016-00171
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ATRICURE INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0387.A. UPON INSPECTION, IT WAS FOUND THAT THE OPENING CABLE WAS JAMMED BETWEEN THE TOGGLE AND THE PULLEY IN THE END EFFECTOR, WHICH INTERFERED WITH THE NORMAL OPENING AND CLOSING ACTIONS. THE DESCRIPTION STATES THAT THE PHYSICIAN WAS ATTEMPTING TO CLOSE THE TOOL IN ORDER TO REMOVE IT FROM THE CAVITY, IMPLYING THAT THE CLIP WAS DEPLOYED WITH THE DEVICE IN THE OPEN POSITION. THIS IS NOT ADVISED. THE TOOL SHOULD BE USED TO CLOSE THE CLIP DOWN ONTO THE APPENDAGE BEFORE DEPLOYMENT IS INITIATED.

    Description of Event or Problem · 1

    DURING A TT LAA EXCLUSION, THE DOCTOR OPENED AND CLOSED THE DEVICE TWO OR THREE TIMES DURING PLACEMENT. DELIVERY OF THE CLIP WAS SUCCESSFUL AND UNEVENTFUL. WHEN ATTEMPTING TO RETRIEVE THE DELIVERY HANDLE, SURGEON WAS UNABLE TO CLOSE THE JAWS, SIMPLY REMOVED THE PORT OUT THROUGH THE SKIN INCISION WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844383 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE INC. PRO245 68551

    Patients

    Seq Age Sex Outcome Treatment
    1