BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6262448 · Received January 18, 2017

    Report

    Report Number
    3003502395-2017-00014
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    November 10, 2016
    Report Date
    January 16, 2017
    Manufacturer
    ATRICURE INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. BASED ON THE COMPLAINT DESCRIPTION, THE MOVING SIDE SUTURE ATTACHMENT WAS TIED INCORRECTLY AROUND THE PULL BAR DURING MANUFACTURING. THIS LEFT THE CLIP TETHERED TO THE DEVICE AT THAT ATTACHMENT POINT UNTIL THE SURGEON WAS ABLE TO CUT IT OFF. BECAUSE THE SURGEON SAW THE DEFECT AND WAS ABLE TO MANUALLY REMOVE THE CLIP BY CUTTING THE SUTURE, THE FAILURE CANNOT BE REPLICATED DURING THIS EVALUATION. HOWEVER, THE FAILURE MODE WILL BE INVESTIGATED ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A MVR/MAZE PROCEDURE, A PRO140 WAS DEPLOYED PROPERLY BUT WHEN RETRACTING THE METAL BAR, THE STRING FROM THE DISTAL END OF THE METAL BAR CAUGHT ONTO THE CLIP RESULTING IN THE SURGEON HAVING TO CUT THE STRING TO FULLY RETRACT THE METAL BAR AND REMOVE THE CLIP DEPLOYER. THE PATIENT WAS ON-PUMP AND HEPARINIZED WITH AN UNKNOWN AMOUNT. THERE WAS NO DELAY IN THE CASE AS IT ONLY TOOK SECONDS TO CUT THE STRING AND PATIENT CARE OR OUTCOME WERE NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44468 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE INC. PRO140 66344

    Patients

    Seq Age Sex Outcome Treatment
    1