BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6473187 · Received April 7, 2017

    Report

    Report Number
    3011706110-2017-00037
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0387.B. ALL 3 DEVICES EVALUATED REVEALED THAT THE CABLES INSIDE THE HANDLE CONTROLLING THE UP/DOWN ARTICULATION HAD PULLED OUT OF THEIR ANCHOR POINTS, CAUSING SLACK IN THE SYSTEM AND PREVENTING THE DEVICE FROM MAINTAINING POSITION IN THAT DIRECTION WHEN LOCKED. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    DURING A THORACOTOMY OF A LEFT ATRIAL APPENDAGE MANAGEMENT, A PRO245 WAS BROUGHT THROUGH THE PORT AND MANEUVERED DOWN AND SLIGHTLY TO THE LEFT. VERY LIGHT PRESSURE WAS PLACED ON THE DEVICE AND IT LOST ITS RIGIDITY AND WENT LIMP AND WAS UNABLE TO BE CONTROLLED. THE FACILITY WENT THROUGH A TOTAL OF 3 PRO245'S AND ALL FAILED IN THE SAME MANNER. THE ACCOUNT HAD ALSO OPENED AN ACH245, WHICH WAS UNABLE TO BE PLACED ON THE PATIENT (NO MALFUNCTION OF THE DEVICE) AND THEREFORE WASTED. THE CASE WAS COMPLETED USING A PRO250 CLIP. THE CASE WAS FINISHED AND TEE SHOWED THE APPENDAGE WAS CLOSED TO SATISFACTION OF THE SURGEON AND CARDIOLOGIST. THE PROCEDURE WAS PROLONGED FOR THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254765 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. PRO245 (3) 70093

    Patients

    Seq Age Sex Outcome Treatment
    1 ACH245 LOT NUMBER 71050 MANF. 2/3/17 EXP. 1/1/20