BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

    MDR report key: 1234065 · Received November 4, 2008

    Report

    Report Number
    9616099-2008-02595
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    KO30409
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL AND TESTING; HOWEVER, THE ENGINEERING EVAL IS NOT COMPLETE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT WHILE PREPARING FOR AN INTERVENTIONAL PROCEDURE, WHEN THE PACKAGE OF THE SMARTER 8 X 40MM STENT WAS OPENED, THE PHYSICIAN NOTED THAT THE STENT WAS PARTIALLY EXPOSED AND RELEASED APPROXIMATELY 5 CM. THE PRODUCT APPEARED NORMAL ON INSPECTION AND THE BOX FOR THE PRODUCT WAS INTACT AND NOT DAMAGED. THE Y-CONNECTOR WAS ENCLOSED. THE TARGET LESION FOR THE PROCEDURE WAS THE BILIARY DUCT. THE PRODUCT WAS NOT CLINICALLY USED IN THE PT. ANOTHER SMARTER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 13269567

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR