BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1610159 · Received February 5, 2010

    Report

    Report Number
    1610159
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 5, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTED ARTERIAL ACCESS OF LEFT FEMORAL ARTERY, THE PHYSICIAN WAS UNABLE TO ADVANCE A GUIDEWIRE AND REQUESTED A GLIDEWIRE (TERUMO GLIDEWIRE 0.035X150CM) TO BE AVAILABLE. HE PROCEEDED WITH USE OF THE GLIDEWIRE THROUGH THE ACCESS NEEDLE, WHICH IS AGAINST THE MANUFACTURER RECOMMENDATIONS (WARNING LABEL ON PACKAGE; (DO NOT USE WITH MEDAL ENTRY NEEDLE). WHEN UNABLE TO ADVANCE THE GLIDEWIRE, HE REMOVED THE GLIDEWIRE AND EVENTUALLY ABORTED PROCEDURE. ON INSPECTION OF THE GLIDEWIRE, IT WAS NOTICED THAT APPROX 3 INCHES OF HYDROPHILIC COATING WAS MISSING FROM ONE SIDE OF THE DISTAL END OF THE GLIDEWIRE. THE PHYSICIAN WAS ALERTED AND SHOWN THE DAMAGED AREA OF GLIDEWIRE (APPARENTLY SHEARED BY THE NEEDLE'S BEVEL). INSPECTION OF THE PT AND SURROUNDING AREA BY VISUAL AND FLUOROSCOPIC MEANS DID NOT REVEAL THE MISSING PORTION. MD WAS INFORMED WITHOUT NEW ORDERS. PHYSICIAN NOTED EVENT IN CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE GLIDEWIRE DQX TERUMO MEDICAL CORP. RFGA35153A 090604

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other