BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL STENT SYSTEM

    MDR report key: 1972691 · Received January 21, 2011

    Report

    Report Number
    MW5019136
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) WOMAN WITH BILATERAL URETERAL OBSTRUCTION AND HYDRONEPHROSIS POST RADIATION THERAPY FOR UTERINE MALIGNANCY. SHE HAD BILATERAL NEPHROSTOMIES WITH PLANS TO REPLACE WITH URETERAL STENTING. RIGHT STENT WAS PLACED WITHOUT EVENT. DURING PLACEMENT OF STENT IN LEFT URETER, STENT FRACTURED. SUBSEQUENTLY THE LEFT NEPHROSTOMY WAS RETAINED. URINE CULTURES WERE NEGATIVE. NEPHROSTOGRAM WAS DONE AND DEMONSTRATED ADEQUATE DRAINAGE OF URINE FROM THE LEFT KIDNEY TO THE BLADDER, THEREFORE THE LEFT NEPHROSTOMY WAS REMOVED AND THE PT WAS DISCHARGED. THE PT AND THE ATTENDING PHYSICIAN WERE INFORMED OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL STENT SYSTEM URETERAL STENT SYSTEM FAD BOSTON SCIENTIFIC F8 X 22CM 11586954

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR