BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEWIRE GT

    MDR report key: 2022032 · Received March 11, 2011

    Report

    Report Number
    2022032
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    TERUMO
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, A GLIDEWIRE FRACTURED WHILE IN THE PATIENT AND BECAME LODGED IN AN ARTERY SUPPLYING THE LIVER. WE WERE ABLE TO SUCCESSFULLY SNARE THE WIRE OUT OF THE PATIENT AND SHE DID FINE WITH THE REMOVAL. THE MD COMMENTS: UNSURE HOW THIS HAPPENED, THE WIRE MAY HAVE DRIED OUT, THE PART ON THE TOWEL AND DURING THE INSERTION PROCESS MAY HAVE STUCK AND TORQUES THE WIRE ENOUGH TO BREAK IT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDEWIRE GT GUIDEWIRE DQX TERUMO RG*GW1818SA 101008

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR