BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIR-SPHERES Y-90 RESIN MICROSPHERES DELIVERY SYSTEM

    MDR report key: 5517553 · Received March 22, 2016

    Report

    Report Number
    5517553
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    October 30, 2015
    Report Date
    November 4, 2015
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    IWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR SELECTIVE INTERNAL RADIATION THERAPY (SIRT) FOR LIVER TUMOR. DURING PROCEDURE IT WAS NOTICED THAT THERE WAS A LEAKAGE ON THE MEMBRANE OF THE V VIAL AFTER FIRST INJECTION. ATTEMPT WAS MADE TO SEAL THE LEAK BUT TO NO AVAIL. THE DECISION WAS MADE TO ABORT THE PROCEDURE DUE TO POSSIBLE EXPOSURE TO STAFF, PATIENT, AND PROCEDURE ROOM. ALL POSSIBLE EXPOSURE AREAS WERE SCANNED BY PHYSICIST AND THERE APPEARED TO BE NO EXPOSURE. THE DELIVERY BOX AND ALL CONTAMINATED MATERIALS WERE PUT INTO A RED BAG. IT IS ESTIMATED THAT PATIENT RECEIVED LESS THAN 10% OF THE PRESCRIBED DOSE. RADIATION ONCOLOGIST SPOKE WITH PATIENT AND PROCEDURE WILL BE RESCHEDULED. NO PATIENT HARM IDENTIFIED AS A RESULT. MANUFACTURER RESPONSE FOR SELECTIVE INTERNAL RADIATION THERAPY (SIRT) - V VIAL, SIR-SPHERES Y-90 RESIN MICROSPHERES DELIVERY SYSTEM (PER SITE REPORTER): PLACING DERMA BOND TO THE V-VIAL BEFORE ADMINISTRATION OF THE DOSE IN ORDER TO PREVENT ANY POSSIBILITY OF LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173623 SIR-SPHERES Y-90 RESIN MICROSPHERES DELIVERY SYSTEM SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL IWJ SIRTEX MEDICAL LIMITED N/A 081521

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NO