BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEWIRE

    MDR report key: 7464065 · Received April 26, 2018

    Report

    Report Number
    7464065
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 7, 2018
    Report Date
    April 17, 2018
    Manufacturer
    TERUMO CORP.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN ACCESSING THE CEPHALIC VEIN FOR A PACEMAKER INSERTION, A GLIDEWIRE WAS INSERTED INTO THE VEIN AND THE WIRE INTRODUCER WAS ALSO ADVANCED INTO THE VEIN. GLIDEWIRE WAS REMOVED FROM THE VEIN BUT NOT THE INTRODUCER. WE WERE UNABLE TO VISUALIZE THE INTRODUCER UNDER FLUORO. BASED ON PACKING LISTS FOR DEVICES PURCHASED FOR THE CATH LAB PRIOR TO PROCEDURE LOT# COULD BE 171113.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306649 GLIDEWIRE CARDIAC/PERIPHERAL VASCULAR GUIDEWIRE, SINGLE-USE DQX TERUMO CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other