BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTATRON SYSTEM

    MDR report key: 2070558 · Received April 1, 2011

    Report

    Report Number
    2133936-2011-00009
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P950014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR ANALYSIS. THE LOCATION BALLOON WAS FILLED WITH 10CC OF WATER. UPON VISUAL INSPECTION, WATER WAS OBSERVED LEAKING FROM THE AREA WHERE THE BALLOON FILL TUBING IS CONNECTED TO THE BALLOON FILL STOPCOCK. THE DEVICE HISTORY RECORD FOR THE CATHETER WAS REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES, AND THE DEVICE MET SPECIFICATIONS AT THE TIME OF RELEASE. IT IS NOTED THAT PER UROLOGIX USER MANUAL, PRE-TESTING OF THE LOCATION BALLOON WITH STERILE WATER IS REQUIRED BEFORE INSERTING THE CATHETER INTO THE PATIENT, HOWEVER, THIS WAS NOT PERFORMED. THE LOOSE CONNECTION BETWEEN THE BALLOON FILL TUBING AND STOPCOCK MOST LIKELY CONTRIBUTED TO THE LOCATION BALLOON DEFLATING. HOWEVER, THE ROOT CAUSE OF THE LOOSE CONNECTION BETWEEN THE BALLOON FILL TUBING AND STOPCOCK REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER LOCATION BALLOON LEAK OCCURRED DURING A TRANSURETHRAL MICROWAVE TREATMENT. THE PHYSICIAN INSERTED THE CATHETER WITHOUT ANY ISSUES. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE LOCATION BALLOON WITH STERILE WATER, WATER WAS OBSERVED LEAKING FROM WHERE THE BALLOON FILL TUBING CONNECTS TO THE BALLOON FILL STOPCOCK. IT IS NOTED THAT PER UROLOGIX USER MANUAL, TESTING OF THE LOCATION BALLOON WITH STERILE WATER IS REQUIRED BEFORE INSERTING THE CATHETER INTO THE PATIENT, HOWEVER, THIS WAS NOT PERFORMED BEFORE TREATMENT. THE LOCATION BALLOON LEAK OCCURRED PRIOR TO ENERGY DELIVERY TO THE CATHETER. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 220983 110006

    Patients

    Seq Age Sex Outcome Treatment
    1