BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM GUIDEWIRE

    MDR report key: 2122173 · Received June 13, 2011

    Report

    Report Number
    2939204-2011-00337
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K050964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INSPECTION OF THE RETURNED DEVICE NOTED SLIGHT BENDS AT 49CM AND 105CM FROM THE PROXIMAL END. THESE WERE MOST LIKELY CAUSED BY HANDLING OF THE DEVICE DURING PREPARATION. EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE PTFE COATING HAD BEEN SLIGHTLY PEELED UP FROM THE STAINLESS STEEL CORE WIRE 23CM FROM THE PROXIMAL END. THE TORQUE DEVICE BRASS COLLETT MARKINGS APPEARED TO BE ON THE GUIDEWIRE. FROM THE CONDITION OF THE GUIDEWIRE IT APPEARED THAT THE TORQUE DEVICE HAD BEEN DRAGGED AT THE SECTION WHERE THE COATING WAS MISSING DUE TO INSUFFICIENT TIGHTENING OF THE TORQUE DEVICE. THERE WAS SLIGHT RESISTANCE ENCOUNTERED ADVANCING THE DEVICE THROUGH A DEMONSTRATION CATHETER DUE TO THE BENDS NOTED ON THE DEVICE. NO OTHER ANOMALIES WERE FOUND. THE DIRECTIONS FOR USE SPECIALLY WARNS THAT INSUFFICIENT TIGHTENING OF THE TORQUE DEVICE CAN LEAD TO PTFE COATING PEELING. THEREFORE, THIS IS CONSIDERED TO BE USE/USER ERROR.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING FROM THE PROXIMAL SECTION OF THE DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO 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 M001509000 B19303

    Patients

    Seq Age Sex Outcome Treatment
    1