BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    MDR report key: 1002630 · Received February 8, 2008

    Report

    Report Number
    2134265-2008-00378
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY PROCEDURE, A STENT DEPLOYED PREMATURELY. THE SENTINOL BILIARY STENT DELIVERY SYSTEM WAS PREPPED AS PER THE DIRECTIONS FOR USE. THE SENTINOL BILIARY STENT DELIVERY SYSTEM WAS THEN BEING LOADED ON THE GUIDE WIRE, AND UPON INSPECTION, IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED. THERE WAS NEVER ANY PT CONTACT WITH THIS DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES.

    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 11311712

    Patients

    Seq Age Sex Outcome Treatment
    1 YR