BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873962 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00019
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    January 14, 2025
    Report Date
    August 22, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETROSPECTIVE MDR HAS BEEN FILED FOR THE POTENTIAL OF SERIOUS INJURY. THE RADIATION CONTAMINATION AND DEVICE MALFUNCTION CAUSED THE PATIENT'S TREATMENT TO 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. SIRTEX HAS LEARNED THE PATIENT WAS SUCCESSFULLY TREATED ON THE RESCHEDULED DATE AND RECEIVED THE DOSE TO THE INTENDED TARGET. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES.

    Description of Event or Problem · 0

    THE HOSPITAL HAD A Y90 PROCEDURE FOR A REPEAT PATIENT. THE DOSE WAS DRAWN AND DELIVERED BY JUBILANT RADIO PHARMA. WHEN THE TIME CAME FOR THE ADMINISTRATION, THE SIROS DELIVERY SYSTEM WAS SET UP AND THE DELIVERY SET WAS FLUSHED WITH D5W. ONCE THE LINES WERE FLUSHED, WE CONNECTED THE A LINE TO THE MICRO CATHER WITH A WET-TO-WET CONNECTION AND THEN PROCEEDED TO CHECK ON THE MICROCATHETER POSITION UNDER FLUOROSCOPY. AT THAT TIME, THE DOCTOR ASKED TO HAVE THE D-VIAL PLACED INTO THE SIROS DELIVERY SYSTEM AND THE D LINE WAS DISCONNECTED FROM THE RED CONNECTOR AND MARRIED TO THE D PIGTAIL FROM THE VIAL AND THEN THE C LINE PIGTAIL WAS CONNECTED TO THE C PIGTAIL ON THE D-VIAL COMPLETING THE SYSTEM. ONCE THE SYSTEM WAS COMPLETED, WE RECHECKED THE CATHETER POSITIONING AND THEN PROCEEDED TO ADMINISTRATION. USING A 20CC SYRINGE - THE DOCTOR BEGAN ADMINISTRATION AND AT FIRST THE DOSE STARTED TO AGITATE IN THE VIAL AND AS WE WATCHED WE DID NOT SEE MICROSPHERES LEAVING THE VIAL THROUGH THE C LINE. THE DOCTOR COMMENTED THAT HE WAS HAVING TROUBLE PUSHING THE SYRINGE AND WAS GETTING PRESSURE. THE DOCTOR TRIED TO PUSH A FEW MORE TIMES AND THERE WAS NO VISIBLE DOSE MOVING INTO THE C LINE FROM THE DOSE VIAL. THE LINES WERE VISUALLY INSPECTED TO MAKE SURE THAT THE CONNECTIONS LOOKED PROPER WHICH THEY DID - THE DOCTOR AND I CONVERSED AND AGREED THAT IT SEEMED THAT THERE WAS A BLOCKAGE OF SOME KIND FROM THE VIAL TO THE C LINE. THERE WAS NO VISIBLE LEAKING COMING FROM ANYWHERE IN THE LINES. I INSPECTED THE GREEN NIPPLE IN THE D-VIAL AS BEST I COULD AND IT LOOKED CLEAR AND COULD NOT ASCERTAIN ANYTHING THAT WOULD CAUSE THE BLOCKAGE OF THE DOSE EXITING THE VIAL. THE DOCTOR ASKED ME TO CHECK THE PIG TAIL LINES BY REMOVING THE LID AND MAKING SURE THAT THEY WERE NOT OCCLUDED OR KINKED CAUSING THE BLOCKAGE. I REMOVED THE LID AND HANDED THE SIROS DOME LID TO THE RADIATION SAFETY REPRESENTATIVE WHO WAS BEHIND ME IN THE DOORWAY. HE TOOK THE LID FROM ME. I PROCEEDED TO LOOK AT THE C & D PIGTAILS WHERE THEY EXIT FROM THE VIAL AND COULD NOT ASCERTAIN ANY PINCHING OR AREAS THAT WOULD CAUSE BLOCKAGE OF THE LINE EXITING THE D VIAL. THE C LINE LOOKED COMPLETELY CLEAR AT THIS POINT - NO DOSE HAD LEFT THE VIAL. I CHECKED THE C LINE CONNECTION JUST TO MAKE SURE THEY WERE TIGHT AND ALSO CHECKED THE D LINE CONNECTION TO MAKE SURE THAT WAS TIGHT. THE FACT THAT WE WERE ABLE TO PUSH SOME D5W INTO THE VIAL INITIALLY SEEMED TO INDICATE THE ISSUE WAS NOT IN THE D LINE ENTERING THE VIAL BUT THE C LINE EXITING THE VIAL AS WE HAD INCREASING PRESSURE IN THE VIAL AND ALSO THERE WAS NOT DOSE VISIBLY EXITING THE VIAL. I ASKED FOR THE LID TO BE GIVEN TO ME TO REPLACE THE SIROS DOME BACK ON AND THE DOCTOR TRIED TO PUSH AGAIN SEVERAL MORE TIMES AND AGAIN THE DOSE WAS UNABLE TO MOVE FORWARD. AT THAT TIME, WE WERE AT A LOSS AS TO WHAT COULD BE THE CAUSING THE BLOCKAGE. AT THAT TIME, THE RADIATION SAFETY REPRESENTATIVE SAID HIS HANDS WERE HOT. WE IMMEDIATELY STOPPED THE PROCEDURE AND DETERMINED THAT WE WOULD NOT BE ABLE TO TREAT THE PATIENT AND THAT WE HAD ROOM CONTAMINATION AND STARTED TO ADOPT RADIATION SPILL PROCEDURES FOR THE ANGIO SUITE. DOSE VIAL ARRIVED WITH 14.3 MCI DRAWN. THE PRODUCT WAS NOT CONTAMINATED UPON RECEIPT AND CHECKED. SIROS DOME WAS SET UP PROPERLY AND D-VIAL WITH DOSE WAS CONNECTED INTO THE SYSTEM PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667458 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1142053 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown