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

Model Number	SIR-10300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event involved no threat to public health and no death or serious injury to the patient.The ifu has precautions for handling radiation.Two lot numbers were provided in the complaint.Sirtex was unable to determine which or if it was both batch numbers that malfunctioned.A batch record review was performed and did not result in any abnormal findings for either batch.A retrospective mdr will be filed out of an abundance of caution due to the potential for serious injury should the device leak and the full dose not be able to be administered.
Event or Problem Description
Following the completion of the administration, a small puddle of liquid underneath the "y" connection on the delivery set was identified.Once the microcatheter, d-vial, and delivery set were removed, the lid to the siros dome was placed on top of the base.The siros delivery dome was then surveyed and results came back hot.The siros delivery dome was then placed into an appropriate decay location.

• Brand Name: SIROS DELIVERY SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL PTY LIMITED; shop 6, 207 pacific highway; st. leonards 2065 ; AS 2065
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; floor 2; woburn, MA 01801
• MDR Report Key: 22873071
• Report Number: 9710358-2025-00006
• Device Sequence Number: 20284478
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)241129(17)261129(10)10556145
• 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 Model Number: SIR-10300
• Device Lot Number: 10556145, 10556146
• 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: 06/15/2023
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown