BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC COIL

    MDR report key: 1211518 · Received October 22, 2008

    Report

    Report Number
    2939204-2008-00492
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE: OTHER-FOR NO ALLEGATION OF ANY DEVICE MALFUNCTION OR NON CONFORMANCE THAT CONTRIBUTED TO THE EVENT. RELATED MFR REPOTS FILED FOR THIS EVENT: TRANSEND 300 FLOPPY GUIDEWIRE: 2939204-2008-00493. NEUROFORM 3.5 X 15 MM: 2939204-2008-00491. NEUROFORM 3.5 X 20MM STENT: 2939204-2008-00494.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COILING OF A WIDE NECK ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY, THE FIRST STENT ATTEMPTED COULD NO BE PLACED AND WAS REMOVED WITHOUT ANY ISSUE. A SECOND STENT WAS PLACED WITH EASE AND THE ANEURYSM WAS SUCCESSFULLY FILLED WITH GDC COILS (DEVICE IN QUESTION). PATIENT STATUS IS REPORTED AS "OK", WITH THE EXCEPTION OF "A LIGHT DEFICIT IN MOVEMENT OF THE LEFT LEG." IT WAS REPORTED THAT THE DEFICIT IN MOVEMENT OF THE LEFT LEG WAS DUE TO A SMALL INFRACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other TRANSEND 300 FLOPPY GUIDEWIRE| NEUROFORM 3.5 X 15 MM STENT| NEUROFORM 3.5 X 20 MM STENT