BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC

    MDR report key: 1013069 · Received February 27, 2008

    Report

    Report Number
    1013069
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    December 7, 2007
    Report Date
    February 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY THE TARGET GUGLIELMI DETACHABLE COIL INTO THE LEFT OPHTHALMIC ANEURYSM. THE COIL WOULD NOT ADVANCE INTO THE ANEURYSM, SO THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL THROUGH THE MICROCATH. THE COIL STRETCHED INTO THE AORTA. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE COIL. TWO ATTEMPTS WERE SUCCESSFUL; HOWEVER, EVENTUALLY THE STRETCHED COIL BROKE. BOTH PIECES WERE RETRIEVED FROM THE PATIENT. THE MANUFACTURER REQUESTED THE DEVICE BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC COIL, ANEURYSM HCG BOSTON SCIENTIFIC CORPORATION * 9569548

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR