BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE .008 HYDROPHILIC GUIDEWIRE

    MDR report key: 1111742 · Received August 13, 2008

    Report

    Report Number
    2029214-2008-00137
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 15, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Adverse Event
    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 (MANUFACTURE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GUIDEWIRE WAS USED FOR NAVIGATION IN A CEREBRAL AVM TREATMENT. AFTER DIFFICULTY WITH NAVIGATION, THE GUIDEWIRE WAS WITHDRAWN FOR SELECTIVE ANGIOGRAPHIC CONTROL. DURING REMOVAL, THE DISTAL SEGMENT SEPARATED AND WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. 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 5182258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention