BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1211520 · Received October 22, 2008

    Report

    Report Number
    2939204-2008-00493
    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
    DQX
    PMA / PMN Number
    K022357
    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 REPORTS FILED FOR THIS EVENT: GDC DETACHABLE COILS: 2939204-2008-00492. NEUROFORM 3.5 X 15 MM STENT: 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 NOT BE PLACED AND WAS REMOVED WITHOUT ANY ISSUE. A SECOND STENT WAS PLACED WITH EASE AND THE ANEURYSM WAS SUCCESSFULLY FILLED WITH GDC COILS. 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 INFARCTION. THE TRANSEND GUIDEWIRE (DEVICE IN QUESTION) WAS USED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE (DQX) WIRE, GIDE, CATHETER DQX BOSTON SCIENTIFIC CORP. 46-815 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other NEUROFORM 3.5 X 15 MM STENT| GDC DETACHABLE COILS (NUMBER OF COILS UNK)| NEUROFOM 3.5 X 20 MM STENT