BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC-10)

    MDR report key: 204572 · Received December 30, 1998

    Report

    Report Number
    6000078-1998-00186
    Event Type
    Malfunction
    Date Received
    December 30, 1998
    Date of Event
    December 7, 1998
    Report Date
    December 30, 1998
    Manufacturer
    TARGET THERAPEUTICS A BOSTON SCIENTIFIC COMPANY
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TARGET THAT DURING THE PROCEDURE THE GDC COIL PREMATURELY DETACHED AT THE WELD. THE COIL WAS SUCCESSFULLY PLACED IN THE ANEURYSM AND THERE WAS NO IMPACT TO THE PT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC-10) Implant DATACHABLE COIL HCG TARGET THERAPEUTICS A BOSTON SCIENTIFIC COMPANY NA A59693

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR 1) TRACKER-18, INFUSION CATHETER. CATALOG #13XXXX.