BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDE WIRE M

    MDR report key: 11094 · Received January 28, 1994

    Report

    Report Number
    MW1000513
    Event Type
    Injury
    Date Received
    January 28, 1994
    Date of Event
    January 4, 1994
    Report Date
    January 5, 1994
    Manufacturer
    MEDI TECH, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ANGIOGRAM THE MD REMOVED THE GUIDEWIRE FROM THE INTRODUCING NEEDLE. IT WAS NOTED THAT A PIECE OF THE TEFLON COATING HAD PEELED OFF AND REMAINED IN THE PT IN THE PROXIMITY OF THE AXILLARY ARTERY. THE MD WAS USING THE AXILLARY APPROACH FOR THE PROCEDURE. THE TEFLON WAS REMOVED ON 1/6/94. IT WAS APPROX TWO INCHES IN LENGTH AND WAS LOCATED IN THE SOFT TISSUE IN THE AXILLARY AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GUIDE WIRE M DQX MEDI TECH, INC. RFGS35153 8892F15

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention