BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3 MICRO THERAPEUTICS, INC

    MDR report key: 902273 · Received August 20, 2007

    Report

    Report Number
    MW5003517
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    August 17, 2007
    Report Date
    August 20, 2007
    Manufacturer
    MICR THERAPEUTICS, INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GUIDE WIRE SHREDDED DURING UTERINE EMBOLIZATION PROCEDURE. CORE WIRE DELOCKED FROM SPRING. NO PATIENT INJURY OCCURRED BECAUSE OF THIS. GUIDE WIRE REMOVED WITHOUT INCIDENT. NOT SURE OF LOT NUMBER; NOT ABLE TO RETRIEVE PACKAGING FROM TRASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV3 MICRO THERAPEUTICS, INC SILVER SPEED GUIDE WIRE DQX MICR THERAPEUTICS, INC 3244992 OR 3065345

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other