BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    MDR report key: 1161316 · Received September 11, 2008

    Report

    Report Number
    2134265-2008-02605
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE STENT DELIVERY SYSTEM FROZE ON THE GUIDE WIRE. THE LESION WAS LOCATED IN THE LEFT SUBCLAVIAN ARTERY. THE NATURE OF THE LESION IS UNK. THE SENTINOL 7MM X 59MM X 135CM SELF-EXPANDING NITINOL BILIARY STENT SYSTEM, WAS ADVANCED OVER ANOTHER MFR'S GUIDE WIRE, AND FROZE ON IT. BOTH SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM AND GUIDE WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PT'S STATUS WAS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11774788

    Patients

    Seq Age Sex Outcome Treatment
    1