BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM GUIDEWIRE

    MDR report key: 2181819 · Received July 28, 2011

    Report

    Report Number
    2939204-2011-00390
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K050964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENTTHE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. VISUAL INSPECTION OF THE RETURNED DEVICE DISCOVERED THAT THE GUIDEWIRE HAD SEPARATED AT ITS DISTAL SECTION 178.9CM FROM ITS PROXIMAL END. THE CORE WIRE OF THE GUIDEWIRE, NITINOL (NITI) TUBINGS AND PLATINUM COIL WERE SEPARATED. THE GUIDEWIRE PLATINUM COIL WAS SEVERELY STRETCHED. THE NITI WAS BENT AND SLIGHTLY STRETCHED EXPOSING THE DISTAL END OF THE CORE WIRE. THE GUIDEWIRE WAS BENT IN SEVERAL PLACES. IT WAS ALSO BENT JUST PROXIMAL TO THE SEPARATED SITE. THE GUIDEWIRE'S SEPARATED DISTAL SECTION WAS NOT RETURNED. NO OTHER ANOMALIES WERE NOTED. IT APPEARED THAT THE GUIDEWIRE MIGHT HAVE SEPARATED DURING THE TIP SHAPING PROCESS DUE TO EXCESSIVE FORCE. THE DEVICE DIRECTIONS FOR USE INSTRUCT USERS TO ¿CAREFULLY SHAPE THE GUIDEWIRE TIP WHILE THE OBSERVED STRETCHING SUGGESTS THAT THE GUIDEWIRE SEPARATED DURING THE TIP SHAPING PROCESS, THE DISTAL PORTION OF THE SUBJECT DEVICE WAS NOT RETURNED, SO THIS COULD NOT BE DEFINITIVELY IDENTIFIED AS A CAUSE OR CONTRIBUTOR. AS A RESULT, A ROOT CAUSE OF UNDETERMINABLE WAS ASSIGNED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DISTAL TIP OF THE GUIDEWIRE HAD DETACHED. THE DEVICE HAD NOT BEEN USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FATHOM GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M001509100 B20100

    Patients

    Seq Age Sex Outcome Treatment
    1