BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 3170005 · Received June 10, 2013

    Report

    Report Number
    MW5030522
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 10, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC STENTING AND WHILE REMOVING THE GUIDEWIRE IT ATTACHED TO THE STENT AND THE GUIDEWIRE BROKE. LEAVING A SIGNIFICANT PIECE IN THE PT THAT REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261457 RUNTHROUGH NS PTCA GUIDE WIRE DQX TERUMO MEDICAL CORPORATION 130305

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization