BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRAGE .008 HYDROPHILIC GUIDEWIRE

    MDR report key: 1111858 · Received August 13, 2008

    Report

    Report Number
    2029214-2008-00140
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 13, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE WAS RETURNED WITH THE COREWIRE IN TWO BROKEN SEGMENTS. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT SHOWED THE FAILURE OF THE COREWIRE OCCURRED DUE TO TORSIONAL OVERLOAD. THE INITIAL REPORT STATES, THE GUIDEWIRE WAS USED WITH A MAGIC 1.2F CATHETER (MANUFACTURED BY BALT). THE MIRAGE GUIDEWIRE IS NOT COMPATIBLE WITH THE MAGIC 1.2F DUE TO THE LUMEN ID OF THE CATHETER. THIS LIKELY LED TO DIFFICULTY NAVIGATION AND THE GUIDEWIRE BROKE OFF DURING MANIPULATION. RESULTS - GUIDEWIRE BROKEN. (B) (4).

    Description of Event or Problem · 1

    TREATMENT OF A CEREBRAL AVM. DURING GUIDEWIRE NAVIGATION, IT WAS REPORTED THAT IT WAS DIFFICULT TO NAVIGATE WITH THE GUIDEWIRE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE .008 HYDROPHILIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0608 5835349

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK