BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTURA

    MDR report key: 3918240 · Received June 27, 2014

    Report

    Report Number
    3918240
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 27, 2014
    Manufacturer
    HOLOGIC, INC
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD CONTURA PARTIAL RADIATION CATHETER PLACED. PRIOR TO PLACEMENT THE SURGEON CHECKED THE BALLOON. AFTER PLACEMENT PATIENT HAD CT SCAN AT OUTPATIENT TREATMENT CENTER TO ENSURE PLACEMENT AND BALLOON PATENCY; WHICH WAS GOOD. THREE DAYS LATER THE PATIENT RETURNED TO OUTPATIENT TREATMENT CENTER FOR TREATMENT AND THE BALLOON HAD POPPED. RADIATION TREATMENT COULD NOT BE COMPLETED AND THE CATHETER WAS REMOVED. PATIENT WAS OFFERED TO HAVE ANOTHER CATHETER PLACED BUT PATIENT DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376059 CONTURA CATHETER JAQ HOLOGIC, INC * REXJ0575

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR UNKNOWN.