BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTATRON SYSTEM

    MDR report key: 1887406 · Received October 26, 2010

    Report

    Report Number
    2133936-2010-00021
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 21, 2010
    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. VISUAL INSPECTION FOR THE CATHETER REVEALED A LARGE TEAR IN THE LOCATION BALLOON. 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. A TEAR IN THE LOCATION BALLOON WAS CONFIRMED, HOWEVER, THE ROOT CAUSE OF THE EVENT IS 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 AND INFLATED THE LOCATION BALLOON. WHEN ATTEMPTING TO SEAT THE LOCATION BALLOON IN THE PATIENT'S BLADDER NECK, NO RESISTANCE COULD BE FELT AND THE CATHETER WAS PULLED OUT. UPON REMOVAL OF THE CATHETER, THE LOCATION BALLOON WAS TESTED AND A LEAK IN THE BALLOON WAS CONFIRMED. 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 WAS DETECTED 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 110001

    Patients

    Seq Age Sex Outcome Treatment
    1