BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 ULTRASOFT COIL

    MDR report key: 1231920 · Received November 13, 2008

    Report

    Report Number
    2939204-2008-00570
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 23, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON-CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM BY WAY OF COIL EMBOLIZATION. "HEMATOMA SEEMED TO BE RESOLVED, HOWEVER, EDEMA WAS ENHANCED AFTER THE COIL EMBOLIZATION. THE PT RAN A FEVER CONTINUOUSLY TWO DAYS POST PROCEDURE." FOUR WEEKS POST PROCEDURE, CT AND MRI SCANS WERE PERFORMED, SHOWING A "RING-ENHANCING ABSCESS". THE PHYSICIAN PERFORMED SURGERY TO REMOVE THE ABSCESS AND THE COIL MASS. THE ANEURYSM WAS SUBSEQUENTLY TREATED. THE COIL MASS WAS SENT FOR CULTURE AND TESTED POSITIVE FOR GRAM POSITIVE COCCI. AFTER THE REMOVAL OF THE "COIL MASS", THE PT'S CONDITION IMPROVED. PATIENT'S CURRENT STATUS IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 ULTRASOFT COIL (HCG) DETACHABLE COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION 343203

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention EXCELSIOR MICROCATHETER| FOUR GDC-10 ULTRASOFT COILS| SYNCHRO GUIDEWIRE (BOSTON SCIENTIFIC CORP)