BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 2999921 · Received March 12, 2013

    Report

    Report Number
    2133936-2013-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 13, 2013
    Manufacturer
    UROLOGIX, INC
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CATHETER WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER CONFIRMED THAT THE LOCATION BALLOON WAS LEAKING NOT FROM THE GLUE SEAMS BUT A PRESSURE PUNCTURE HOLE. FOLLOW-UP WITH THE APPLICATION SPECIALIST PRESENT FOR THE TREATMENT INDICATED THAT THERE WAS DIFFICULTY DURING INSERTION. HOWEVER, THE BALLOON WAS TESTED PRE-TREATMENT AND WAS PASSING. BASED ON THIS INFORMATION, IT IS LIKELY THAT THE LOCATION BALLOON WAS DAMAGED DURING THE INSERTION PROCESS.

    Description of Event or Problem · 1

    APPROXIMATELY A THIRD OF THE WAY THROUGH TREATMENT, IT WAS DETECTED BY ULTRASOUND THAT THE ANCHOR BALLOON HAD BEEN LEAKING AND NOT HOLDING THE 10CC'S OF WATER. THE DR. ELECTED TO PULL THE ENTIRE KIT, RTU AND CATHETER AND START COMPLETELY OVER WITH ALL NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103826 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC 410097-001 121024MCA1

    Patients

    Seq Age Sex Outcome Treatment
    1