BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22873375 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00011
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    January 5, 2024
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETROSPECTIVE MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY. THE PHYSICIAN STATED THAT THE PATIENT MIGHT HAVE TO COME BACK TO FULLY TREAT THE TUMOR. THE DEVICE WAS RETURNED TO SIRTEX FOR INVESTIGATION BUT THE EVENT WAS NOT REPLICATED. 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

    3 DOSE SPLIT - 3 GBQ (10.8MCI-.4 GBQ, 13.5 MCI-.5 GBQ AND 24.3MCI-.9 GBQ) DRAW WAS DONE BY JUBILANT RADIOPHARMACY ON (B)(6) 2024. FIRST DOSE ADMINISTERED BY THE PHYSICIANS (ACTUALLY PUSHED ON THE D LINE) GOT ABOUT 1ML IN AND THEN MOVED TO B LINE TO FOLLOW WITH STRAIGHT CONTRAST RUN (SHE KNOWS WE RECOMMEND 50/50, WE DISCUSSED). PHYSICIAN WENT BACK TO THE D LINE AND TRIED TO PUSH FELT RESISTANCE AND SIR-SPHERES STARTED TO COME OUT OF THE D-VIAL. WE STOPPED IMMEDIATELY AND ASSESSED THE SITUATION. WE MADE SURE ALL LINES WERE TIGHT/HOOKED UP PROPERLY (AS THEY WERE WENT STEP BY STEP IN THE BEGINNING), DISCUSSED A POSSIBLE KINKED CATHETER OR SHEATH THAT COULD KINK CATHETER, BUT PHYSICIAN DID NOT FEEL THAT WAS THE CASE. WE WERE IN DISTAL VESSELS AND AT THE TIME WE WERE TREATING SEGMENT 5 WITH THIS 10.8MCI DOSE. PHYSICIAN THEN BAGGED UP EVERYTHING (SIROS, DELIVERY TUBING, D-VIAL AND CATHETER) AND SENT TO NUCLEAR MEDICINE TO MEASURE. READING WAS HIGH, BUT WAS NOT A DIRECT COMPARISON IN THE BEGINNING NO NALGENE BOTTLE/ACRYLIC BOTTLES USED JUST THE DOSE SITTING SEATED IN SIROS UNIT AND TUBING WRAPPED UP. PHYSICIAN WANTED TO PULL ANOTHER DOSE, BASED ON WHAT WAS DELIVERED, BUT WAS UNABLE TO GET AN ACCURATE READING WITH JUBILANT GONE FOR THE DAY AS THE CASE STARTED LATE. DISCUSSION WERE HAD TO TROUBLE SHOOT. PHYSICIAN TREATED THE OTHER TWO TUMORS IN SEGMENT 5 AND 8 AND LEFT THIS ONE ALONE SINCE THEY DID NOT SAFELY KNOW HOW MUCH WAS ACTUALLY DELIVERED IN 1ML AND JUBILANT WAS GONE. PHYSICIAN USED 50/50 CONTRACT ON THE LAST TWO DELIVERIES - B LINE. DELIVERED TWO OTHER DOSES WITH 94% DELIVERED AND SUCCESSFULLY COMPLETED THE CASE AROUND 6/6:15PM CST ON (B)(6). PATIENT WAS NOT HARMED AND DOCTOR PLANNED TO REASSESS BRINGING THE PATIENT BACK TO TREAT THE FIRST TUMOR. FEW THINGS TO CONSIDER THEY RAN OUT OF 10CC/20CC SYRINGES SO THE 2 AND 3RD TO DOSES WERE DELIVERED WITH A 30CC. WIRE USED: FATHAM WIRE180CM, TRUESELECT (BOSTON SCI) WAS THE MICRO CATH.021, 155C, VERSE NORMAL 120CM BECAUSE OF PRODUCT AVAILABILITY. (B)(6) 2024 SPOKE TO JUBILANT AND THEY STATED NOTHING FELT OFF DURING THE DOSE DRAW AND GOT IT ON SECOND ATTEMPT EVEN WITH A SMALL DOSE OF 10.8MCI. JUBILANT PULLED 3% HIGHER ON THE 10.8MCI AND 6 % HIGHER ON THE 13.5 MCI AND .8% HIGHER ON THE 24.3 MCI. THE TRASH BAG WITH CONTAMINATED GOODS IS SITTING IN NUCLEAR MED DECAYING AND REQUESTED THEM TO HANG ONTO AS I WILL SEND BACK TO THE COMPANY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495223 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10300 1109070 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other