BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6638578 · Received June 13, 2017

    Report

    Report Number
    3011706110-2017-00052
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 10, 2017
    Report Date
    June 13, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0271.F. THOUGH THE CLIP WAS DEPLOYED, IT WAS NOTED THAT ONE OF THE SUTURE ATTACHMENTS HAD MORE SLACK IN IT THAN NORMAL WHICH INDICATES THAT IT MAY HAVE BEEN TIED AROUND THE PULL BAR OF THE DEVICE. A FORMAL INVESTIGATION HAS BEEN OPENED BY ENGINEERING TO TRACK AND ANALYZE THIS FAILURE MODE. THE INVESTIGATION RESULTED IN RETRAINING OF MANUFACTURING PERSONNEL ON THE CLIP TYING PROCESS STEP.

    Description of Event or Problem · 1

    DURING A CONCOMITANT AF EPICARDIAL AND LEFT ATRIAL APPENDAGE PROCEDURE, AN ATRICLIP PRO1 WAS PLACED CORRECTLY ON THE LAA. WHEN THE DOCTOR WENT TO REMOVE THE APPLIER, THE CLIP SLID ALONG THE APPENDAGE. THE SURGEON OBSERVED BLEEDING FROM AN UNKNOWN SOURCE. THE CASE WAS CONVERTED TO A STERNOTOMY AND THE SURGEON FOUND THE SOURCE OF THE BLEED, IT WAS AT THE BASE OF THE APPENDAGE. THE SURGEON SURGICALLY CORRECTED THE ISSUE AND DESPITE THE STERNOTOMY, THE PATIENT WAS DOING FINE AND IN SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418246 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. ATRICLIP PRO GILINOV-COSGROVE LAA EXCLUSION SYSTEM 45 69967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention