BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPHILIC COATED GUIDEWIRE

    MDR report key: 1211847 · Received October 10, 2008

    Report

    Report Number
    1211847
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    August 19, 2008
    Report Date
    October 10, 2008
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO POSTION GLIDE WIRE WITH TORQUE DEVICE, VASCULAR SUGEON NOTICED THE HYDROPHILIC COATING ON THE GLIDE WIRE WAS STRIPPED OFF. NO HARM TO PT. DAMAGED PART OF WIRE NEVER ENTERED PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROPHILIC COATED GUIDEWIRE GUIDEWIRE DQX TERUMO MEDICAL CORPORATION * 080418

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR