BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 MICROCATHETER

    MDR report key: 805891 · Received January 3, 2007

    Report

    Report Number
    6000078-2007-00008
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    December 6, 2006
    Report Date
    December 6, 2006
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    PMA / PMN Number
    k013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K)#'S: K042568 AND K994155. THE DEVICE IN QUESTION HAS BEEN RETURNED TO THE MFR AND IS CURRENTLY IN PROCESS OF EVAL. BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 12/16/06, AN EMBOLIZATION PROCEDURE OF THE POSTERIOR CEREBRAL ARTERY THAT "THE EMBOLIZATION WAS PERFORMED AT VEIN OF GALEN ANEURYSMAL MALFORMATION. A (GUIDEWIRE) WAS INSERTED INTO THE CATHETER (DEVICE IN QUESTION) AND THE (DEVICE IN QUESTION) WAS ADVANCED THROUGH THE 4FR GUIDING CATHETER. THEN, IT WAS APPROACHED TO THE LESION AND TWO (COILS) WERE DEPLOYED. AFTER THAT, A LEAK WAS NOTED AT THE PROXIMAL MARKER UNDER THE ANGIOGRAPHY. IT (DEVICE IN QUESTION) WAS REMOVED FROM THE BODY. NO ANOMALY WAS NOTED AT VISUAL INSPECTION." IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE, THAT THERE WERE NO PT COMPLICATIONS AND THAT THE PT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 MICROCATHETER 74 DQO - INFUSION CATHETER DQO NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP 168189 8929386

    Patients

    Seq Age Sex Outcome Treatment
    1 * THERAPY DATE:| THERAPY DATE :| 2 GDC COILS| 4FR GUIDING CATHETER (MANUFACTURER UNK)| DASHER10 GUIDEWIRE