BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON DILATION CATHETER

    MDR report key: 1172485 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04690
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME AS MFR REPORT# 3005099803-2008-04689. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, TWO BALLOON BURST OCCURRED. THE LOCATION OF THE LESION IS UNKNOWN. THE UROMAX ULTRA URETERAL DILATATION CATHETER WAS ADVANCED TO LESION, HOWEVER, UPON AN UNSPECIFIED INFLATION THE BALLOON BURST. THE DEVICE WAS REMOVED, AND A SECOND OF THE SAME DEVICE WAS ADVANCED TO THE LESION, HOWEVER, THIS BALLOON BURST ON AN UNSPECIFIED INFLATION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A THIRD OF THE SAME DEVICE. IT WAS NOTED THAT THE ATMS EACH BALLOON REACHED WEREN'T "ANYWHERE NEAR THE MAXIMUM" RATED BURST PRESSURE (RBP). NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON DILATION CATHETER EZN - URETERAL DILATATION EZN BOSTON SCIENTIFIC M0062251210 11829662

    Patients

    Seq Age Sex Outcome Treatment
    1