BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ULTRA URETERAL STENT

    MDR report key: 1181524 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04833
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DUE TO THE LOT NUMBER NOT BEING PROVIDED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT EXCHANGE CYSTOSCOPY PROCEDURE, THE STENT WAS FELT TO BE READY TO "FALL APART". A POLARIS ULTRA URETERAL STENT HAD BEEN SELECTED TO TREAT AN UNSPECIFIED URETERAL STRICTURE. WHILE PREPARING THE DEVICE, THE DEVICE APPEARED TO BE "VERY WEAK" AND "READY TO FALL APART". THE PHYSICIAN DID NOT USE THE DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER TYPE OF STENT. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'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 M0061921330

    Patients

    Seq Age Sex Outcome Treatment
    1