BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1517953 · Received October 20, 2009

    Report

    Report Number
    2939204-2009-00785
    Event Type
    Malfunction
    Date Received
    October 20, 2009
    Date of Event
    September 22, 2009
    Report Date
    September 28, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K): K031049. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENT ASSISTED COIL EMBOLIZATION OF A MIDLINE BASILAR TIP ANEURYSM, A COIL BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT BUT ALL THE COILS WERE REPORTED TO HAVE BEEN SUCCESSFULLY IMPLANTED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC DETACHABLE COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR (BOSTON SCIENTIFIC)| TWO NEUROFORM 3 STENTS AND NINE GDC COILS