BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDE WIRE M

    MDR report key: 18928 · Received November 22, 1994

    Report

    Report Number
    18928
    Event Type
    Injury
    Date Received
    November 22, 1994
    Date of Event
    November 9, 1994
    Report Date
    November 21, 1994
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ABDOMINAL AORTA AND BILATERAL FEMORAL ARTERIOGRAM WITH SERIES OUTPATIENT PROCEDURE IN RADIOLOGY, A PROBLEM DEVELOPED INSERTING THE GUIDE WIRE. THE PHYSICIAN MET RESISTANCE INSERTING THE GUIDE WIRE AND DECIDED TO WITHDRAW THE WIRE. THE PHYSICIAN STARTED TO REMOVE THE WIRE AND THE COATING OVER THE WIRE STARTED TO SPLIT OPEN. THE WIRE WAS COMPLETELY REMOVED AND THE CASE WAS DISCONTINUED. THE PT WAS EXAMINED AND RELEASED WITH NO APPARENT SIGNS OF COMPLICATIONS. DEVICE TO BE SENT TO CO FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GUIDE WIRE M GUIDE WIRE DQX MEDI-TECH, INC. RF*GA35153 8894F24

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention