BEUDAMED
    FDA Adverse Event Death Summary report: N

    GDC 18-FIBERED VORTX SHAPE COIL

    MDR report key: 1081218 · Received July 22, 2008

    Report

    Report Number
    2939204-2008-00298
    Event Type
    Death
    Date Received
    July 22, 2008
    Date of Event
    May 29, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510K : K001083. NO DEVICE MALFUNCTION FOR THE COIL IN QUESTION WAS ALLEGED.

    Description of Event or Problem · 1

    UNDER LOCAL ANESTHESIA, THIRTEEN NON-BOSTON SCIENTIFIC COILS ANS ONE BOSTON SCIENTIFIC COIL WERE PLACED INTO THE SINUS RECTUS AND SIGMOID SINUS WITHOUT ISSUE. THE PHYSICIAN WAS "UNABLE TO DETACH THE NEXT COIL (NON-BSC) PROPERLY". AFTER IMAGING, IT WAS ATTEMPTED TO REMOVE THE NON-BSC COIL AND CATHETER TOGETHER AND IT APPEARED THE COIL WAS MASS MOVED. THE PT LOST CONSCIOUSNESS AND A CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE AT THE "LEFT POSTERIOR SUBCRANIAL". THE PT DID NOT RECOVER AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 18-FIBERED VORTX SHAPE COIL (84 HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 353026-4 9179453

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death A GT GUIDE WIRE (MFR UNK)| (1) EXCELSIOR 1018 CATHETER| (1) CORDIS 6F ENVOY GUIDE CATHETER| (14) NON-BOSTON SCIENTIFIC COILS (MFR UNK)