BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO THERAPEUTICS, INC

    MDR report key: 803684 · Received January 11, 2007

    Report

    Report Number
    MW1041589
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    December 30, 2006
    Report Date
    January 3, 2007
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COILING ANEURYSM, LEFT INTERNAL CAROTID ARTERY HAD ALREADY PLACED 3 OR 4 COILS. THE 5MM/2CM COMPLEX 1D COIL UNRAVELLED IN THE MICRO CATHETER WHEN PLACEMENT INTO THE ANEURYSM WAS ATTEMPTED. THE UNRAVELLED COIL WAS SUCCESSFULLY REMOVED FROM THE PT. NO PT INJURY. THE 6MM X 10CM GDC 10-SOFT 20SR UNRAVELLED IN THE MICRO CATH BEFORE EVEN MAKING IT TO THE ANEURYSM. THE PHYSICIAN SUCCESSFULLY REMOVED THE DEVICE AND THE PROCEDURE CONTINUED WITHOUT ANY FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO THERAPEUTICS, INC MICROFLEX 10 COIL HCG MICRO THERAPEUTICS, INC. * PO603330
    2 GDC 10-SOFT 2D SR MICROFLEX 10 COIL HCG BOSTON SCIENTIFIC - TARGET * 8375264

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR