BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-18 2D COIL

    MDR report key: 1071402 · Received July 7, 2008

    Report

    Report Number
    2939204-2008-00251
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    April 4, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGED MALFUNCTION OR NONCONFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PT UNDERWENT SUCCESSFUL BALLOON ASSISTED EMBOLIZATION OF A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. POST PROCEDURE THE PT SUFFERED A STROKE WITH SIGNS OF POSTERIOR CEREBRAL ARTERY ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-18 2D COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 352103-4 7864289

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization BALLOON CATHETER| THREE BOSTON SCIENTIFIC MATRIX2 COILS