BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS.

    MDR report key: 3202193 · Received June 28, 2013

    Report

    Report Number
    3003502395-2013-00009
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE PASSED ALL VISUAL INSPECTION HOWEVER IT WAS CONFIRMED THAT THE LOOP WOULD NOT LOCK IN LEFT/RIGHT DIRECTION. THE HANDLE HALVES WERE SEPARATED TO INSPECT THE INTERNAL COMPONENTS OF THE DEVICE AND IT WAS DISCOVERED THAT THE CABLES WHICH CONTROL THE MOVEMENT OF THE LOOP IN THE LEFT/RIGHT DIRECTION HAD SLIPPED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE SURGEON WAS ATTEMPTING TO PLACE AN ARTRICLIP PRO145 AND THE DEVICE'S ARTICULATING NECK FAILED TO LOCK PLACE. THE DEVICE WAS ABANDONED AND A 2ND PRO145 WAS DEPLOYED WITHOUT INCIDENT. THERE WAS A SHORT DELAY AS A RESULT OF HAVING TO CHANGE DEVICES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296129 ARTRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS. CLIP, IMPLANTABLE FZP ATRICURE, INC. PRO145 42468

    Patients

    Seq Age Sex Outcome Treatment
    1