BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 1657785 · Received April 9, 2010

    Report

    Report Number
    2133936-2010-00007
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 15, 2010
    Report Date
    April 8, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE LOCATION BALLOON PORT HAD BEEN CUT FROM THE DEVICE. AN ALTERNATE LUER WAS ATTACHED TO THE DEVICE AND THE BALLOON WAS INFLATED WITH 10CC'S OF WATER. WATER WAS OBSERVED LEAKING FROM A PINHOLE IN THE LOCATION BALLOON. THE DEVICE HISTORY RECORD FOR THIS SERIAL NUMBER, (B)(4), SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. THE LEAK WAS CONFIRMED, HOWEVER, THE ROOT CAUSE OF THE EVENT IS LIKELY ATTRIBUTED TO THE URETHRAL STRICTURE.

    Description of Event or Problem · 1

    IT WAS DETERMINED THAT DURING A TRANSURETHRAL MICROWAVE TREATMENT, A LEAK IN THE CATHETER LOCATION BALLOON OCCURRED. IT WAS REPORTED THAT AFTER TREATMENT, WATER COULD NOT BE EXTRACTED FROM THE LOCATION BALLOON AND THE CATHETER COULD NOT INITIALLY BE REMOVED FROM THE PATIENT. THE BALLOON INFLATION PORT WAS SUBSEQUENTLY CUT FROM THE DEVICE IN AN EFFORT TO DRAIN THE WATER FROM THE BALLOON. HOWEVER, NO WATER WAS OBSERVED COMING OUT OF THE TUBING. THE PHYSICIAN STATED THAT THE PATIENT HAD A URETHRAL STRICTURE AND WAS ABLE TO REMOVE THE CATHETER. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE LOCATION BALLOON WAS DEFLATED. THE LOCATION BALLOON WAS TESTED IN ACCORDANCE WITH APPROVED PROTOCOL BEFORE BEING INSERTED INTO THE PATIENT; NO ISSUES WERE DETECTED DURING TESTING. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 5000A 100202MHA2

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR