BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 24967087 · Received April 23, 2026

    Report

    Report Number
    9710358-2026-00012
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 23, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATH OR SERIOUS INJURY WAS REPORTED AND IT WAS STATED THAT THE PATIENT WAS TREATED SUCCESSFULLY. THE IFU ALSO STATES TO ENSURE NO AIR IS IN THE LINES. SIRTEX PERFORMED INTERVIEWS WITH THE HEALTHCARE FACILITY AND THE THIRD-PARTY PHARMACY WHO PREPARED THE DOSE. THE SUGGESTED POTENTIAL CAUSES FOR THE EVENT OF AIR IN THE D-VIAL AFTER THE DOSE PREPARATION STAGE WERE: A LESS EXPERIENCED TEAM DUE TO EMPLOYEE TURNOVER AT THE THIRD PARTY PHARMACY. POSSIBLY AIR WAS BECOMING TRAPPED IN THE VALVE AND THE THIRD-PARTY PHARMACY DID NOT ENSURE NO AIR WAS IN THE DEVICE SIRTEX IS WORKING WITH THE THIRD-PARTY PHARMACY TO RESOLVE THE ISSUE. SIRTEX MEDICAL AFFAIRS HAS STATED, BASED ON THE AVAILABLE INFORMATION, THE REPORTED AIR BUBBLE WITHIN THE DELIVERY SET VIA THE D-VIAL REQUIRING ASPIRATION, ALONG WITH LOCALIZED SYRINGE BECOMING RADIOACTIVE, IS MOST CONSISTENT WITH A PREPARATION AND HANDLING-RELATED ISSUE RATHER THAN AN INTRINSIC DEVICE MALFUNCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY OR CLINICAL SEQUELAE, SUPPORTING THAT THERE WAS NO MEANINGFUL IMPACT TO PATIENT SAFETY OR TREATMENT DELIVERY. THE OBSERVED FINDINGS ALIGN WITH KNOWN PROCEDURAL RISKS ASSOCIATED WITH SYSTEM PRIMING AND HANDLING OF RADIOACTIVE MATERIAL, AS DESCRIBED IN THE IFU. WHILE THE RISK TO THE OPERATOR APPEARS MINIMAL AND SELF-LIMITED, THE RECURRENCE AT THE SAME SITE SUGGESTS THE NEED FOR REINFORCEMENT OF PROPER PREPARATION AND VERIFICATION STEPS. OVERALL, THE BENEFIT-RISK PROFILE OF THE DEVICE REMAINS UNCHANGED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED STATING MULTIPLE OCCASIONS OF AIR BEING INTRODUCED TO THE DELIVERY SET VIA THE PREPARED DOSE FROM THE D-VIAL. THE DOSE IS PREPARED BY A THIRD PARTY PHARMACY WHICH IS THEN PROVIDED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181004 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL, INC. SIR-10200 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown