BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 GUGLIELMI DETACHABLE COIL

    MDR report key: 290236 · Received August 11, 2000

    Report

    Report Number
    6000078-2000-00075
    Event Type
    Malfunction
    Date Received
    August 11, 2000
    Date of Event
    July 10, 2000
    Report Date
    August 10, 2000
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TARGET THAT WHEN THIS GDC-10 COIL WAS BEING INSERTED INTO THE MICRO CATHETER, IT DETACHED UNEXPECTEDLY WITHOUT ANY CURRENT. THE PT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 GUGLIELMI DETACHABLE COIL DETACHABLE COIL HCG TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION NA A88055

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO