BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC COIL

    MDR report key: 1033293 · Received April 22, 2008

    Report

    Report Number
    2939204-2008-00138
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., CORK, NEUROVASCULAR DIVISION
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    DURING THE EMBOLIZATION OF A RUPTURED BASILAR TIP ANEURYSM, IT WAS REPORTED THAT THE ANEURYSM RUPTURED. THE TREATMENT GIVEN WAS " MEDICATION, SURGERY AND HOSPITALIZATION" NO OTHER DETAILS FOR THE ACTION TAKEN WERE PROVIDED. THE PHYSICIAN ATTRIBUTED THE EVENT TO " THE PROCEDURE , SAH, RUPTURE/ RE-RUPTURE AND POSSIBLY TO THE GDC DEVICE. NO INFO WAS PROVIDED AS TO THE MODEL OF COIL USED, WHEN DURING THE PROCEDURE THE EVENT OCCURRED OR PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP., CORK, NEUROVASCULAR DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BOSTON SCIENTIFIC GDC COILS