BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6725276 · Received July 19, 2017

    Report

    Report Number
    3011706110-2017-00062
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    May 24, 2017
    Report Date
    July 19, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS RETURNED ON 7/7/2017 FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0271.F. THE EVALUATION CONCLUDED THAT THE CABLE WHICH CONTROLS THE UP/DOWN ARTICULATION MOVEMENT OF THE DEVICE WAS NOT TENSIONED PROPERLY. BECAUSE OF THIS, THE LOCK MECHANISM WAS NOT ABLE TO COMPLETELY ENGAGE. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) FEMALE HAD AN ON-PUMP, FULLY HEPARINIZED MVR/LAA PROCEDURE. WHILE THE SURGEON WAS ATTEMPTING TO DEPLOY THE PRO135 DEVICE ON THE LAA, THE DEVICE WOULD NOT ARTICULATE AND THE SURGEON NOTED THAT IT SEEMED A STRING WAS BROKEN INSIDE THE DEVICE. THE CLIP HAD NOT BEEN TESTED PRIOR TO INSERTION INTO PATIENT. THE DEFECTIVE CLIP WAS REMOVED WITHOUT ANY ISSUES AND A SECOND PRO135 WAS PLACED ON THE LAA SUCCESSFULLY. THE PATIENT CARE, OUTCOME AND LENGTH OF THE PROCEDURE WERE NOT AFFECTED. POST INTERVENTION, THE PATIENT WAS DISCHARGED HOME AS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505797 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 35 65739

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR