BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER

    MDR report key: 949039 · Received November 14, 2007

    Report

    Report Number
    6000078-2007-00306
    Event Type
    Injury
    Date Received
    November 14, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): K042568/K994155. THE DEVICE WAS DISPOSED OF BY THE USER FACILITY AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED TO EMBOLIZE AN ANEURYSM IN THE MIDDLE CEREBRAL ARTERY. THE ANATOMY OF THE TARGET LESION WAS REPORTED AS SEVERELY TORTUOUS. AFTER THE SUCCESSFUL PLACEMENT OF TWO COILS, A THIRD COIL WAS ADVANCED TO THE ANEURYSM . THE DISTAL END OF THE CATHETER [DEVICE IN QUESTION] MOVED AS THE COIL WAS BEING POSITIONED. THE ANEURYSM RUPTURED. THE CATHETER WAS REPOSITIONED AND THE COIL WAS DEPLOYED SUCCESSFULLY IN THE ANEURYSM. A FURTHER SEVEN COILS WERE SUCCESSFULLY DEPLOYED IN THE ANEURYSM USING THIS DEVICE. THE PT WAS REPORTED TO BE IN "GOOD" CONDITION POST PROCEDURE. THE PHYSICIAN DOES NOT ALLEGE ANY PRODUCT MALFUNCTION BUT THE MOVEMENT OF THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER (DQO) INFUSION CATHETER DQO BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION 168190 11062427

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other BOSTON SCIENTIFIC SYNCHRO GUIDEWIRE AND| 10 GDC COILS