BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS URETHRAL STENT

    MDR report key: 847163 · Received May 10, 2007

    Report

    Report Number
    6000043-2007-00053
    Event Type
    Injury
    Date Received
    May 10, 2007
    Date of Event
    April 13, 2007
    Report Date
    April 13, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT CONFIRMED. A VISUAL EVALUATION FOUND THAT TWO COLLAPSED AREAS IN THE WORKING LENGTH OF THE STENT. THE EVALUATION ALSO FOUND THAT BOTH PIGTAILS HAD BEEN DEFORMED OUT OF ROUND AND HAD FLAT SECTIONS IN THEM. A FUNCTIONAL EVALUATION FOUND THAT AN 0.038 INCH GUIDEWIRE COULD BE PLACED THROUGH THE BODY OF THE STENT WITH RESISTANCE BEING FELT IN THE DISTAL PIGTAIL AREA WHERE THE OUT OF ROUND ISSUE WAS NOTED. A SHIP HISTORY WAS PERFORMED AND FOUND THAT LOT NUMBERS 9191362, 9202591, AND 9080179 WERE THE LAST THREE LOTS SENT TO THIS CUSTOMER. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBERS 9191362, 9202591, AND 9080179. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS RELATED TO THE PRODUCT FAMILY WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED. THE POLARIS URETHRAL STENT 15-MONTH 2007 COMPLAINT TREND REPORT, INCLUSIVE FOR ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ONE OF OUR POLARIS STENT WAS BEING USED FOR URETHRAL DRAINAGE THAT OCCURRED IN 2007. DURING THE PROCEDURE, THE COIL OF THE STENT DETACHED UPON DEPLOYMENT WITHIN THE PATIENT, IT WAS ALSO NOTED THE ENTIRE STENT APPEARED TO BE VERY FRAGILE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE ENTIRE DEVICE SUCCESSFULLY (METHOD UNKNOWN). NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS URETHRAL STENT FAD FAD BOSTON SCIENTIFIC M0061901240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention