BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 633692 · Received September 8, 2005

    Report

    Report Number
    6000043-2005-00053
    Event Type
    Injury
    Date Received
    September 8, 2005
    Date of Event
    July 29, 2005
    Report Date
    August 11, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A THERAPEUTIC STENT REPLACEMENT THE DISTAL COIL ON THIS STENT BECAME BENT AND STUCK INSIDE THE RENAL PELVIS AND THE URETER. THE DR DECIDED TO LEAVE THE STENT IN AND CHECK THE PT'S CONDITION. THE NEXT DAY THE PT PRESENTED WITH PAIN. HYDRONEPHROSIS WAS DIAGNOSED AND A NEPHROSTOMY WAS PERFORMED TO REMOVE THE STENT, AFTER WHICH THE PT WAS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention