BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELSIOR SL-10 MICROCATHETER

    MDR report key: 845102 · Received May 1, 2007

    Report

    Report Number
    6000078-2007-00124
    Event Type
    Death
    Date Received
    May 1, 2007
    Date of Event
    March 30, 2007
    Report Date
    April 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) #: K042568 AND K994155.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT A CUSTOMER ENCOUNTERED PROCEDURE COMPLICATIONS DURING THE USE OF A MICROCATHETER. THE FOLLOWING INFORMATION WAS REPORTED TO THE MFR: "PROCEDURE INVOLVED EMBOLIZATION OF A PCOMM ANEURYSM: AFTER ATTEMPTED COILING, WHEN THE MICROCATHETER [DEVICE IN QUESTION] WAS BEING WITHDRAWN SLOWLY, THE PROXIMAL SEGMENT [OF THE DEVICE IN QUESTION] BROKE OFF LEAVING ABOUT 2/3 OF THE MICROCATHETER [DEVICE IN QUESTION] STILL IN THE CAVERNOUS SEGMENT OF THE RICA (RIGHT INTERNAL CAROTID ARTERY). THE MICROCATHETER [DEVICE IN QUESTION] WAS RETRIEVED WITH NO PROBLEMS WHEN THE GUIDING CATHETER WAS SUBSEQUENTLY WITHDRAWN. THE ANEURYSM RUPTURED DURING THE PROCEDURE, PROMPTLY CLOTTED OFF THE ANEURYSM, AND THREW A PIECE OF A CLOT INTO THE R CAROTID "T". PATIENT EXPIRED." IT WAS REPORTED THAT THE "PHYSICIAN DID NOT ATTRIBUTE THE CAUSE OF DEATH TO THE DEVICE IN QUESTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 MICROCATHETER DQO: CATHETER / INTRAVASCULAR / DIAGNOSTIC DQO BOSTON SCIENTIFIC CORPORATION 168189 9400114

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| L