BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE

    MDR report key: 691482 · Received January 20, 2006

    Report

    Report Number
    691482
    Event Type
    Other
    Date Received
    January 20, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 20, 2006
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE UNDERGOING A LENGTHY NEURO-INTERVENTIONAL PROCEDURE THE EMBOLIZATION WIRE BROKE OFF. THE FIRST GUIDEWIRE USED WAS RETRIEVED COMPLETELY. THE DISTAL END OF THE SECOND GUIDEWIRE WAS NOT RETRIEVED AND REMAINED IN THE EMBOLIZED VESSEL LEFT POSTERIOR CEREBRAL ARTERY (PCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE GUIDEWIRE, NEURO-INTERVENTIONAL DQX MICRO THERAPEUTICS, INC. 103-0608 1371956
    2 SYNCHRO-14 GUIDEWIRE, NEURO-INTERVENTIONAL DQX BOSTON SCIENTIFIC CORPORATION 1301 B06657

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA