BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOFOCUS GLIDEWIRE

    MDR report key: 2894614 · Received December 26, 2012

    Report

    Report Number
    2894614
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    TERUMO CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PART OF THE GLIDEWIRE SHEARED OFF DURING THE PROCEDURE AND THE PIECE WAS RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION GLIDEWIRE, ANGLED, 260 CM 120724

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR