BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1522749 · Received November 3, 2009

    Report

    Report Number
    2939204-2009-00825
    Event Type
    Injury
    Date Received
    November 3, 2009
    Date of Event
    October 26, 2009
    Report Date
    October 27, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 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

    DURING A ROUTINE TWELVE MONTH F/U VISIT ANGIOGRAPHY REVEALED A WORSENING OF THE ANEURYSM OCCLUSION. A SECOND PROCEDURE WAS THEN PERFORMED THREE MONTHS LATER TO RE-OCCLUDE THE ANEURYSM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention GDC-10 360 SR COIL, MODEL# M003346720SR0| BOSTON SCIENTIFIC| GDC-10 ULTRASOFT COIL, MODEL# M0033433080| BOSTON SCIENTIFIC| 3 GDC-10 360 SOFT SR COILS, MODEL# M003347509SR0| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| GDC-10 ULTRASOFT COIL, MODEL# M0033432560| BOSTON SCIENTIFIC| 3 GDC-10 ULTRASOFT COILS, MODEL# M0033432060| BOSTON SCIENTIFIC| GDC-10 SOFT 2D SR COIL, MODEL# M003344308SR40| BOSTON SCIENTIFIC| GDC-10 SOFT 2D SR COIL, MODEL# M003344508SR40| GDC-10 SOFT 2D SR COIL, MODEL# M003344510SR40| GDC-10 360 SOFT SR COIL, MODEL# 003347408SR0| TWO GDC-10 360 SR COILS, MODEL# M003346515SR0| BOSTON SCIENTIFIC| GDC-10 360 SR COIL, MODEL# M003346615SR0| BOSTON SCIENTIFIC| GDC-18 360 SR COIL, MODEL# M0033489200| THIRTY GDC COILS (BOSTON SCIENTIFIC)| BOSTON SCIENTIFIC| 3 GDC-10 SOFT 2D SR COILS, MODEL# M003344506SR40| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| 2 GDC-10 ULTRASOFT COILS, MODEL# M0033432030| 3 GDC-10 SOFT 2D SR COILS, MODEL# M003344408SR40| BOSTON SCIENTIFIC| 3 GDC-10 ULTRASOFT COILS, MODEL# M0033432040