BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6511558 · Received April 21, 2017

    Report

    Report Number
    3011706110-2017-00040
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 27, 2017
    Report Date
    March 27, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CASE-(B)(4) THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0387 A. IT WAS REPORTED THAT THE CLIP HAD TO BE CUT FROM THE DEPLOYMENT TOOL. UPON INSPECTION, IT WAS FOUND THAT A FRAGMENT OF THE DEPLOYMENT CABLE AND THE PROXIMAL SUTURE TIE ON THE PULL BAR WERE LEFT ATTACHED. BOTH HAD BEEN CUT AS REPORTED. THE TIP OF THE DEPLOYMENT CABLE IS INTACT, BUT THERE IS A DAMAGED/KINKED PORTION PROXIMAL TO THE TIP THAT HAS CREATED A SNAG POINT. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    WHEN CLIP WAS DEPLOYED AND RUBBER STOPPER PULLED, SUTURES BROKE AND CLIP HAD TO BE CUT FROM THE FRAME. THE CLIP WAS PROPERLY PLACED. THE CASE WAS DELAYED FOR THREE MINUTES, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293350 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. PRO135 72089

    Patients

    Seq Age Sex Outcome Treatment
    1