MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LTD SIROS DELIVERY SET; System, applicator, radionuclide, manual

Model Number	SIR-10300
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related death or serious injury was reported.The ifu and training manual state to ensure air is removed from the lines and specifically to ensure the wet to wet connection on the c-lines to prevent air from being introduced.A review of production records show the batch was manufactured to approved specifications and met all quality assurance criteria.A retrospective mdr has been filed due to this potential for serious injury as there is a potential risk of air embolism should the lines not be properly flushed.
Event or Problem Description
There was a significant column of air that came out of the d vial during the first aliquot of the administration, specifically from the c-line connections.The lines were flushed with approx.40 ccs of d5w prior to administration.Physician would like to know where the air is coming from, inside the d-vial or is there an issue with the delivery sets.Is it possible to look at flushing the d-line and c-line independently? i suspect that the air has something to do with the red connector piece, i have noticed that it is loose and not secure during the priming process and the lines become disconnected.

• Brand Name: SIROS DELIVERY SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL PTY LTD; 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: 22878233
• Report Number: 3005579300-2025-00020
• Device Sequence Number: 10371567
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)240807(17)260807(10)1142008
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• 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 Expiration Date: 08/07/2026
• Device Model Number: SIR-10300
• Device Lot Number: 1142008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2024
• 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