BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 691318 · Received March 22, 2006

    Report

    Report Number
    6000043-2006-00026
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    February 13, 2006
    Report Date
    February 21, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO URETERAL STENT WERE PLACED IN THE PT APPROXIMATELY 2-3 WEEKS AGO FO THERAPEUTIC UROLOGICAL DRAINAGE.DURING STENT WITHDRAWAL,THE PIGTAIL OF THE FIRST STENT DETACHED IN THE PT'S URETER(PLEASE REFERENCE MW 6000043-2006-00025 FOR ADDITIONAL PT DETAILS).EITHDRAWAL OF THIS STENT WAS UNEVENTFUL,HOWEVER OT WAS NOTED THE STENT WAS SPLIT,BUT INTACT.NO SEGMENTS OF THE DEVICE DETACHED.SEVERAL ATTEMPS AT RETRIEVAL OF THE DETACHED SEGMENT WERE UNSUCCESSFUL.A STENT WAS PLACED FOR CONTINUED DRAINAGE AT THAT TIME.THE PT REMAINED HOSPITALIZED AND EXPERIENCED A FEVER OF 103. THE PT WAS PLACED ON ANTIBIOTICS.A SECOND PROCEDURE WAS PERFORMED MARCH 13,2006,AT WHICH TIME THE DETACHED SEGMENT WAS PUSHED UP INTO THE RENAL PELVIS RESULTING IN THE STENT SEGMENT BREAKING INTO PIECES.A SNARE WAS UTILIZED TO RETRIEVE THE DETSACHED STENT SEGMENTS,HOWEVER,THE STENT CONTINUED TO BREAK INTO PIECES.A SMALL 8MM SEGMENT OF THE STENT STILL REMAINS IN THE PT'S MID-URETER.TO DATE,NO ADDITIONAL RETRIEVAL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DETACHED SEGMENT.THE PT WILL BE MONITORED.SHOULD THE PT BECOME SYMPTOMATIC,ANOTHER PROCEDURE WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX URETERAL STENT PERCUFLEX URETERAL STENT FAD BOSTON SCIENTIFIC NA 7201241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN