BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIRTEX Y-90 SIR

    MDR report key: 4858630 · Received June 12, 2015

    Report

    Report Number
    4858630
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 19, 2015
    Report Date
    June 12, 2015
    Manufacturer
    SIRTEX WILMINGTON LLC
    Product Code
    NAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DUE TO SEVERAL INSTANCES OF SUSPENDED SIRTEX Y-90 SIR-SPHERE MICROSPHERES IN THE 3-WAY STOPCOCK "C" LINE ENTRY PORT, AN INVESTIGATION WAS CONDUCTED INTO THE DELIVERY BOX USED FOR SELECTIVE INTERNAL RADIATION THERAPY. THE RESULTS IDENTIFIED A MISALIGNMENT OF THE INTERNAL VALVE OF THE 3-WAY STOPCOCK DUE TO IMPRECISE TOLERANCES IN THE DELIVERY BOX FABRICATION.THE DELIVERY BOX STOPCOCK CONTROL KNOB IS LIMITED TO A QUARTER TURN WHEN ENGAGED ON THE STOPCOCK. IMAGES FROM A LIGHT MICROSCOPE SHOWED THE MISALIGNMENT OF THE DELIVERY BOX STOPCOCK CONTROL KNOB CAUSED THE UNDER-ROTATION OF THE INTERNAL HOLE IN THE STOPCOCK.WHEN THE STOPCOCK CONTROL KNOB IS TURNED TO ALLOW INCOMING FLOW FROM THE C-LINE, THE INTERNAL STOPCOCK HOLE IS ROTATED UPWARDS. THE ROTATION CAN CREATE A SIGNIFICANT VOID FOR MICROSPHERE ACCUMULATION.ALSO IDENTIFIED IN THE INVESTIGATION BY OUR MEDICAL PHYSICISTS WAS IMPROVED DELIVERY RESULTS WHEN USING STERILE WATER TO SUSPEND THE Y-90 SIR-SPHERES AND D5W/CONTRAST TO FLUSH.======================MANUFACTURER RESPONSE FOR SELECTIVE INTERNAL RADIATION (SIR) THERAPY DELIVERY BOX, SIRTEX Y-90 SIR-SPHERE MICROSPHERES DELIVERY BOX (PER SITE REPORTER).======================SIRTEX HAS SEEN THIS ISSUE PREVIOUSLY AND IS PROVIDING US WITH ANOTHER DELIVERY BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386272 SIRTEX Y-90 SIR SYSTEM, APPLICATION, RADIONUCLEOTIDE NAW SIRTEX WILMINGTON LLC DELIVERY BOX B *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER DEVICES KNOWN TO CONTRIBUTE