BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIRTEX V-VIAL

    MDR report key: 465570 · Received June 10, 2003

    Report

    Report Number
    9710358-2003-00002
    Event Type
    Malfunction
    Date Received
    June 10, 2003
    Date of Event
    May 14, 2003
    Report Date
    June 3, 2003
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT FAILED TO RECEIVED TREATMENT AS THE DELIVERY APPARATUS FOR IMPLANTING SIR-SPHERES FAILED TO MAINTAIN AN AIR-TIGHT SEAL. INVESTIGATIONS TO DATE INDICATE THAT THE FAILURE OF THE SEAL RESULTED FROM A DOUBLE PUNCTURE OF THE V-VIAL SEPTUM WHEN LOADING THE PT READIATION DOSE. THE SECOND PUNCTURE WAS ATTEMPTED THROUGH THE INITIAL PUNCTURE HOLE, IN ALL LIKELIHOOD CAUSING A SUFFICIENTLY LARGE HOLE IN THE SEPTUM TO ALLOW LOSS OF AIR SPACE AND AN EXTREMELY SMALL QUANTITY OF FLUID FROM THE VIAL. THE APPARATUS IS STILL TOO READIOACTIVE TO BE RETURNED FOR EXAMINATION BY SIRTEX. PT TREATMENT WAS RESCHEDULED AND CONDUCTED SUCCESSFULLY. THIS WAS AN UNNECESSARY ADDITIONAL INTERVENTIONAL UNDERTAKEN IN ORDER TO PROVIDE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIRTEX V-VIAL EXTERNAL COMMUNICATING DEVICE NAW SIRTEX MEDICAL LIMITED SIR-V001 1116

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other