BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    MDR report key: 1083385 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02110
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 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

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING OF THE SENTINOL 8MM X 42MM X 1350MM SELF-EXPANDING NITINOL BILIARY STENT SYSTEM, A STENT DISLODGEMENT WAS NOTED. THE STENT WAS PARTIALLY PROTRUDING OUT OF THE CATHETER. THE DEVICE HAD NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    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 8876592

    Patients

    Seq Age Sex Outcome Treatment
    1