BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELSIOR SL-10 MICROCATHETER

    MDR report key: 761483 · Received September 15, 2006

    Report

    Report Number
    6000078-2006-00430
    Event Type
    Death
    Date Received
    September 15, 2006
    Date of Event
    September 6, 2006
    Report Date
    September 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV
    Product Code
    DQO
    PMA / PMN Number
    k013789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K042568/K994155. THE DEVICE IN QUESTION HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED DURING A PROCEDURE ON AN ANEURYSM IN THE CAVENOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA), THE CATHETER WAS ADVANCED INTO THE MIDDLE CEREBRAL ARTERY (MCA) OVER A GUIDEWIRE. THE GUIDE WIRE WAS THEN REMOVED AND A 300CM CHOICE EXTRA SUPPORT WIRE WAS ADVANCED. ATTEMPTS TO WITHDRAW THE CATHETER WERE MADE, LEAVING THE WIRE IN POSITION. HOWEVER, THE PHYSICIAN REPORTED THE WIRE BECAME STUCK TO THE CATHETER, AND MAY HAVE ENTERED ONE OF THE SMALL BRANCHES OF THE PT'S ARTERY DURING ATTEMPTS TO REMOVE THE CATHETER. THE PT SUBSEQUENTLY DEVELOPED A SUBARACHNOID HEMORRHAGE (SAH) AND EXPIRED TWO HRS FOLLOWING THE PROCEDURE. THE PHYSICIAN REPORTED RESISTANCE WAS THE MAIN ISSUE WHEN TRYING TO REMOVE THE CATHETER OVER THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 MICROCATHETER INFUSION CATHETER DQO BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV 168189 7859627

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death CHOICE EXTRA SUPPORT WIRE 300 CM| TRANSEND 0.14 GUIDEWIRE (MODEL UNK)