BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ULTRA

    MDR report key: 1081515 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01296
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    PMA / PMN Number
    K010002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR A UROLOGY STENTING TREATMENT PROCEDURE STENT DAMAGE WAS NOTICED. A POLARIS ULTRA URETERAL STENT HAD BEEN SELECTED FOR USE. WHILE PREPARING THE DEVICE IT WAS NOTICED THAT THE PROXIMAL PIGTAIL HAD A "TEAR". THERE WERE NO PATIENT COMPLICATIONS WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ULTRA URETERAL, STENT FAD BOSTON SCIENTIFIC M0061931330 11488449

    Patients

    Seq Age Sex Outcome Treatment
    1