BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

    MDR report key: 1811086 · Received August 23, 2010

    Report

    Report Number
    9616099-2010-00634
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    KO30409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING AN ATTEMPTED PLACEMENT OF A BILIARY STENT, THE SMARTER 190 WAS DELIVERED TO THE TARGET LESION VIA AN ENDOSCOPE. WHILE THE STENT WAS BEING RELEASED FROM THE SDS, THE SDS STARTED TO MOVE FORWARD TOWARDS THE BILIARY TRACT PER THE REPORTING AFFILIATE. THE PHYSICIAN ABANDONED THE STENT PLACEMENT, AND DECIDED TO REMOVE THE DEVICE. HOWEVER, THE DEVICE BECAME STUCK ON THE UNKNOWN GUIDEWIRE BEING USED AND COULD NOT BE REMOVED OVER THE WIRE. THEREFORE, THE SMARTER 190 AND GUIDEWIRE WERE REMOVED TOGETHER AS A UNIT FROM THE PATIENT. A WALL STENT WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THE TARGET WAS DESCRIBED AS HAVING NO CALCIFICATION AND NO VESSEL TORTUOSITY, WITH AN UNKNOWN STENOSIS. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. A PRELIMINARY ANALYSIS OF THE RETURNED DEVICE RECEIVED ON AUGUST 13, 2010 REVEALED 29CM OF THE INNER SHAFT TO BE DETACHED AND STUCK ONTO AN UNK GW. PER THE AFFILIATE, THE ACCOUNT NOTES THAT THE DETACHMENT OF INNER SHAFT POSSIBLY OCCURRED INSIDE THE PATIENT, AS THE SMARTER 190 WAS PULLED BACK WITH STRONG FORCE.

    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 14141182

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDEWIRE