BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON CATHETER 10CC KIT

    MDR report key: 1161555 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04572
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING URETEROSCOPY PROCEDURE, THE BALLOON RUPTURED. THE TARGET LESION WAS IN AN UNSPECIFIED URETERAL LOCATION. A U2Q/5-10/5.8/75 10CC LIWG KIT HAD BEEN ADVANCED TO THE TARGET LESION. DURING INFLATION, THE BALLOON RUPTURED. THE BALLOON WAS ABLE TO BE REMOVED INTACT WITH NO PIECES LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON CATHETER 10CC KIT EZN BOSTON SCIENTIFIC M0062251360 11476298

    Patients

    Seq Age Sex Outcome Treatment
    1