BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 852416 · Received May 18, 2007

    Report

    Report Number
    2133936-2007-00013
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    April 17, 2007
    Report Date
    May 18, 2007
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    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 BALLOON WAS INFLATED WITH 10 CC OF AMBIENT WATER. UPON INFLATION, A STEADY LEAK WAS CONFIRMED FROM THE INFLATION LUER LOCK. THE DEVICE HISTORY RECORD WAS REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. IT IS NOTED THAT THE LABELING REQUIRES THAT THE LOCATION BALLOON BE CHECKED PRIOR TO USE, AFTER INSERTION AT THE BLADDER NECK AND EVERY 5-10 MINUTES DURING TREATMENT. THE LEAK WAS CONFIRMED, HOWEVER, THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE INFLATION LUER LOCK LEAKED. THE PHYSICIAN INSERTED THE CATHETER AND ABOUT 1-2 MINUTES INTO THE PROCEDURE, THE CATHETER STARTED TO MIGRATE. AN ULTRASOUND WAS PREFORMED AGAIN TO CONFIRM THE LOCATION BALLOON; HOWEVER, THE LOCATION BALLOON COULD NOT BE CONFIRMED. THE CATHETER WAS REMOVED AND RE-EXAMINED, HOWEVER, NO FAILURE WAS NOTICED. THE CATHETER WAS RE-INSERTED AND VERIFICATION OF THE LOCATION BALLOON WAS CONFIRMED BY ULTRASOUND. HOWEVER, ABOUT 1 MINUTE INTO THE PROCEDURE, A LEAK WAS NOTICED IN THE INFLATION LUER LOCK. THE PROCEDURE WAS THEN ABORTED AS THE PATIENT WAS VERY ANXIOUS AND COULD NOT TOLERATE THE TREATMENT. IT IS NOTED THAT THE PATIENT WAS PREMEDICATED WITH ATIVAN, LIDOCAINE, DEMEROL, AND A PROSTATE BLOCK WAS PERFORMED. PHYSICIAN STATED THAT PATIENT WILL BE TREATED BY A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 070131MG1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR