BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUGLIELMI DETACHABLE COILS (GDC)

    MDR report key: 1010511 · Received February 11, 2008

    Report

    Report Number
    1010511
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S DIAGNOSIS WAS A GRADE 4 SUBARACHNOID HEMORRHAGE OF THE RIGHT MIDDLE CEREBRAL ARTERY. DURING COIL PLACEMENT TO CORRECT THE HEMORRHAGE, MULTIPLE ATTEMPTS TO PLACE THE COIL RESULTED IN A FRACTURE OF THE COIL. A FIFTH COIL WAS PLACED WITHIN THE INFERIOR MIDDLE CEREBRAL ARTERY TO SECURE THE BROKEN PIECE OF THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COILS (GDC) COIL, CEREBRAL ANEURYSM HCG BOSTON SCIENTIFIC CORP. * 9067599

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R