BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22591521 · Received July 24, 2025

    Report

    Report Number
    9710358-2025-00003
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 30, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE POTENTIAL SAFETY ISSUE WITH UNDERDOSING AS PROVIDED BY THE SIRTEX MEDICAL TEAM IS AS FOLLOWS: PRIMARY RISK: DISEASE PROGRESSION/INADEQUATE TUMOR CONTROL SIRTEX HAS REQUESTED INFORMATION ON THE PATIENT OUTCOME AND WAS TOLD NO ADDITIONAL TREATMENT WAS REQUIRED. THE CUSTOMER HAS STATED THEY WILL SHIP THE DEVICE TO SIRTEX. SHOULD THE CUSTOMER RETURN THE DEVICE AFTER THE DECAYING PERIOD, SIRTEX WILL PERFORM AN EVALUATION/INVESTIGATION ON THE DEVICE.

    Additional Manufacturer Narrative · 0

    SIRTEX HAS FOLLOWED UP WITH THE CUSTOMER REGARDING THE DEVICE RETURN. NO RESPONSE HAS BEEN RECEIVED. SHOULD THE CUSTOMER RETURN THE DEVICE, SIRTEX WILL PERFORM AN EVALUATION/INVESTIGATION ON THE DEVICE AND SUBMIT A FOLLOW-UP REPORT. THE BATCH RECORD REVIEW DID NOT DISPLAY ANY ABNORMAL FINDINGS FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES.

    Description of Event or Problem · 0

    THE Y PORT OF THE DELIVERY TUBING HAD LARGE AMOUNT OF ACTIVITY (SIR-SPHERES, SIR-Y002) IN IT POST PROCEDURE. THE WRITTEN DIRECTIVE WAS 40MCI AND 17MCI WAS DELIVERED. THE RESIDUAL ACTIVITY WAS ALMOST ENTIRELY IN THE Y PORT OF THE DELIVERY TUBING. THE TREATMENT WAS PERFORMED PROPERLY.

    Description of Event or Problem · 0

    THE Y PORT OF THE DELIVERY TUBING HAD LARGE AMOUNT OF ACTIVITY IN IT POST PROCEDURE. THE ONLY PART OF THE TUBING, INCLUDING THE MICRO AND BASE THAT HAD THAT ACTIVITY. HOSPITAL WOULD LIKE TO HAVE TUBING SENT BACK AND EVALUATED FOR MANUFACTURING ISSUES. TREATMENT PERFORMED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370843 SIROS DELIVERY SET SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL IWJ SIRTEX MEDICAL PTY LIMITED SIR-10300 1142819

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other