BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD CATHETER SET

    MDR report key: 2593900 · Received May 23, 2012

    Report

    Report Number
    9612638-2012-00005
    Event Type
    Other
    Date Received
    May 23, 2012
    Date of Event
    April 16, 2012
    Report Date
    May 1, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC
    Product Code
    JAQ
    PMA / PMN Number
    K952913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USING A THIRD PARTY CLAMPING ADAPTER IS OFF LABEL USE. THE CUSTOMER INTENDS TO REMOVE THE CATHETER FROM THE PT TO REMAIN CONSISTENT WITH THE INFO IN THE INSTRUCTION FOR USE. NO FURTHER F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY USED A STANDARD CATHETER TO IRRADIATE THE CHEST OF A PT ON (B)(6) 2012. THEY USED A METAL BUTTON FROM A THIRD PARTY COMPANY TO FIXATE THE CATHETER, SO THESE DONT' MOVE DURING TREATMENT. ONE OF THESE BUTTONS WAS CRIMPED TOO TIGHT AND CUT THE CATHETER AND A PART OF THE CATHETER REMAINED IN LEFT CHEST CAVITY. CUSTOMER CONFIRMED THAT THE ISSUE WAS DISCOVERED PRIOR TO TREATMENT, AND ACCOUNTED FOR IN THE TREATMENT PLAN WITH NO DEVIATION BETWEEN THE PLANNED AND TREATED DOSE. THE DR ANALYZED THE SITUATION AND IT WAS DECIDED TO LEAVE THE BROKEN PART IN FOREVER AS WHERE IT IS PLACED, THERE IS NO POSSIBILITY OF HARM TO THE PT ACCORDING TO THEIR EVAL. CUSTOMER REPORTED TO VARIAN AFTER THEY READ IN INSTRUCTION FOR USE THAT THE INTENDED USE OF THE CATHETER IS SPECIFIED FOR UP TO 30 DAYS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD CATHETER SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other