BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 23468698 · Received November 4, 2025

    Report

    Report Number
    9710358-2025-00016
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 8, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WAS FILED OUT OF AN ABUNDANCE OF CAUTION, SO SIRTEX MEDICAL COULD LEARN THE OUTCOME OF THE PATIENT'S RESCHEDULED TREATMENT AND TO INVESTIGATE THE DEVICE FOR THE POTENTIAL OF SERIOUS INJURY AS THE MALFUNCTION CAUSED THE PATIENT'S TREATMENT TO BE RESCHEDULED. SIRTEX MEDICAL HAS LEARNED THAT THE PATIENT WAS SUCCESSFULLY TREATED ON THE RESCHEDULED DATE, 97.3% OF THEIR DOSE WAS ADMINISTERED, AND THAT THE PATIENT DID WELL. SHOULD A PATIENT'S TREATMENT BE RESCHEDULED, SIRTEX MEDICAL AFFAIRS HAS STATED A SHORT PROCEDURAL DELAY OF A FEW DAYS UP TO 1 WEEK WOULD BE UNLIKELY TO CAUSE ANY IMMEDIATE OR CLINICALLY SIGNIFICANT CHANGE TO TUMOR BURDEN IN COMMON CASES. THEY ALSO STATED IT WOULD BE RARE FOR A PATIENT TO BE RESCHEDULED FOR OVER TWO WEEKS. THIS EVENT IS CONSIDERED A MALFUNCTION BECAUSE THE DEVICE COULD NOT PERFORM AS INTENDED HOWEVER THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A CHANGE IN THE PATIENT'S CONDITION THAT WOULD BE CONSIDERED A REPORTABLE SERIOUS INJURY. THE REVIEW OF THE BATCH RECORD DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES. NO DEVIATIONS OR ISSUES ASSOCIATED WITH THE LOT WERE FOUND. SIRTEX HAS MADE MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE FOR FURTHER INVESTIGATION, BUT THE DEVICE HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RECEIVED BY SIRTEX, A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.

    Description of Event or Problem · 0

    THE IR EXPERIENCED UNUSUAL RESISTANCE WHEN ATTEMPTING TO DELIVERY THE FIRST ALIQUOT OF THE DOSE. THE DOSE STOPPED AT THE MIDDLE OF THE C-LINE AND WOULD NOT GO ANY FURTHER. AN ATTEMPT TO "UNCLOG" THE DELIVERY SET WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABORT AND RESCHEDULE AS A SECOND DOSE COULD NOT BE DRAWN. IT WAS STATED THAT THE PATIENT WAS FINE.

    Description of Event or Problem · 0

    THE IR EXPERIENCED UNUSUAL RESISTANCE WHEN ATTEMPTING TO DELIVERY THE FIRST ALIQUOT OF THE DOSE. THE DOSE STOPPED AT THE MIDDLE OF THE C-LINE AND WOULD NOT GO ANY FURTHER. AN ATTEMPT TO "UNCLOG" THE DELIVERY SET WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABORT AND RESCHEDULE AS A SECOND DOSE COULD NOT BE DRAWN. IT WAS STATED THAT THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817136 SIROS DELIVERY SET SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL IWJ SIRTEX MEDICAL PTY LIMITED SIR-10300 11428101 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown