BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    MDR report key: 1193279 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02926
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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 A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, A STENT DEPLOYED PREMATURELY. THE LESION LOCATION WAS NOT SPECIFIED. THE TORTUOSITY, PERCENT STENOSIS, AND DEGREE OF CALCIFICATION ARE UNK. THE SENTINOL BILIARY 6X40X135 STENT WAS DEPLOYED, AS IT WAS BEING LOADED ONTO THE GUIDEWIRE. THE PROCEDURE OUTCOME IS UNK. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT CONDITION IS UNK. ATTEMPTS TO OBTAIN ADDITIONAL INFO WERE UNSUCCESSFUL.

    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 11854987

    Patients

    Seq Age Sex Outcome Treatment
    1