BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX PLUS URETERAL STENT

    MDR report key: 1181185 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04926
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED ON AN AXXCESS CATHETER WHICH IS A PART OF THE PERCUFLEX KIT. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A CATHETER TEAR AND DETACHMENT OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED URETER. THE AXXCESS CATHETER WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO REMOVE THE CATHETER, THE PHYSICIAN NOTED THAT THE CATHETER HAD TORN AND A PIECE OF THE DEVICE REMAINED INSIDE THE PATIENT'S BLADDER. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PIECE WITH A FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX PLUS URETERAL STENT FGE BOSTON SCIENTIFIC M006175263010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention