BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6488020 · Received April 12, 2017

    Report

    Report Number
    3011706110-2017-00038
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Report Date
    March 14, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CASE (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO ATRICURE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CASE (B)(4) THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0387.B. THE COMPLAINT WAS CONFIRMED. THE OPENING CABLE HAS MIGRATED OFF THE OPENING CABLE AND BECOME WRAPPED AROUND THE TOGGLE LINK. THIS CAUSED THE OPENING/CLOSING MECHANISM TO JAM. SLACK IN THE OPENING CABLE DUE TO THE JAM ALLOWED IT TO BECOME WEDGED BETWEEN TWO OF THE GEAR TEETH ON THE UP/DOWN ARTICULATION LEVER WHEN THE DEVICE WAS OPENED PREVENTING UP/DOWN ARTICULATION WHEN THE OPENING LEVER IS ACTUATED .

    Description of Event or Problem · 1

    DURING A STAND-ALONE BILATERAL MAZE, LEFT ATRIAL APPENDAGE MANAGEMENT WITH CLIP, A PRO240 WAS PLACED WITHOUT ANY ISSUES TO THE PATIENT. RETRIEVAL OF DEPLOYMENT TOOL WAS NOT POSSIBLE THROUGH THE PORT PROLONGING CASE FOR FIFTEEN MINUTES. PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270257 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. PRO240 66868

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR