BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6091289 · Received November 9, 2016

    Report

    Report Number
    3003502395-2016-00151
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    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 ANALYSIS AND IT WAS DETERMINED THAT THE ROOT CAUSE OF THE FAILURE REPORTED WAS LACK OF CONCENTRICITY OF THE CHAMFERED HOLE ON THE TOGGLE COMPONENT. DUE TO LACK OF CONCENTRICITY THE PULLEY IN THE DEVICE COULD SHIFT FORWARD CREATING AN INHERENT CHANNEL SPACE BETWEEN THE TOGGLE AND THE PULLEY WHERE THE OPENING CABLE COULD WEDGE ITSELF DURING ACTUATION OF THE DEVICE. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEEP STYLE, HYBRID PROCEDURE THE DEVICE WAS TESTED (OPENED AND CLOSED) OUTSIDE OF THE PATIENT THREE TIMES. ONCE INSIDE THE PATIENT AND PLACED AROUND THE APPENDAGE, THE DEVICE WOULD NOT CLOSE. A NEW CLIP WAS OPENED AND PLACED WITHOUT DIFFICULTY. THE CASE WAS DELAYED FOR 5 MINUTES AND THERE WAS NO ADVERSE AFFECT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739543 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE, INC. PRO235 68014

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR