BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1509744 · Received October 13, 2009

    Report

    Report Number
    2939204-2009-00779
    Event Type
    Injury
    Date Received
    October 13, 2009
    Date of Event
    September 18, 2009
    Report Date
    October 8, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K): K042539. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION OR NONCONFORMANCE RELATED TO THE USE OF THESE DEVICES IN THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    APPROXIMATELY TEN MONTHS POST PROCEDURE, THE PATIENT UNDERWENT A SECOND COIL EMBOLIZATION PROCEDURE TO OCCLUDE THE LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM. THREE COILS WERE SUCCESSFULLY PLACED, AND 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 BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention MFR: BOSTON SCIENTIFIC| MFR: BOSTON SCIENTIFIC| GDC-10 360 SOFT COIL: MODEL # M003347408SR0,| TWO GDC-10 ULTRASOFT COILS: MODEL # M0033433060,