BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 SOFT 2D SR COIL

    MDR report key: 963833 · Received December 12, 2007

    Report

    Report Number
    6000078-2007-00337
    Event Type
    Injury
    Date Received
    December 12, 2007
    Date of Event
    November 21, 2007
    Report Date
    November 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA-510(K): K001083

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED FOR AN ANTERIOR COMMUNICATING ANEURYSM IN "VERY TORTUOUS" ANATOMY. THE FIRST COIL WAS SUCCESSFULLY PLACED IN THE ANEURYSM WITHOUT ANY ISSUES. AS THE SECOND COIL [DEVICE IN QUESTION] WAS BEING ADVANCED BEYOND THE CATHETER TIP, BOTH DEVICES MOVED OUT OF THE ANEURYSM. THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE AND THE PROCEDURE WAS TERMINATED. THE PHYSICIAN WAS UNCERTAIN OF THE COIL OR THE CATHETER CAUSED THE BLEEDING. THE PATIENT WAS REPORTED TO BE "STABLE AFTER CRANIOTOMY PERFORMED WAS WITH NO COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 SOFT 2D SR COIL (HCG) GDC COIL HCG BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION 344308-SR4 9441763

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention BOSTON SCIENTIFIC GDC COIL| EXCELSIOR MICROCATHETER