BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS URETERAL STENT / WIRE

    MDR report key: 1140648 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04174
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNKNOWN; CONSEQUENTLY, THE EXPIRATION AND MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. ONE POSSIBLE LOT HAS BEEN IDENTIFIED FOR THE DEVICE; LOT# 11222958. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 11222958 AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISPOSED OF THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 29, 2008, THAT A POLARIS STENT WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, APPROXIMATELY EIGHT DAYS LATER, IT WAS NOTICED THAT THE STENT MIGRATED TO THE RENAL PART OF THE KIDNEY. THE STENT WAS REMOVED WITH A BASKET DEVICE (BRAND UNKNOWN) AND WAS DISPOSED OF. A NEW STENT (UNKNOWN) WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS URETERAL STENT / WIRE FAD BOSTON SCIENTIFIC CORPORATION M006190122010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other