MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIROS D-VIAL PREP SET; System, applicator, radionuclide, manual

Model Number	SIR-10200
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SIROS D-VIAL PREP SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL PTY LIMITED; 207 pacific highway; shop 6; st. leonards 2065 ; AS 2065
• Manufacturer Contact: melissa sanchez ; 300 unicorn park; floor 2; woburn, MA 01801
• MDR Report Key: 22873962
• Report Number: 3005579300-2025-00019
• Device Sequence Number: 13355017
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)241022(17)261022(10)1142053
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIR-10200
• Device Lot Number: 1142053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown