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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A small pool of activity was identified on "the" base of the delivery dome (under the lid on the clear acrylic) at the end of treatment.The pool of liquid was located under the c line connection.No drips coming from the connection were observed during delivery.Ir did not have any issues with connection.C line was not disconnected after treatment.Gloves were not hot.The spill was cleaned and contained.The siros dome was sent to decay.D vial and delivery set were marked to be inspected after decay.96% of dose delivered.
Additional Manufacturer Narrative
The leak was found under the lid of the delivery dome, so the radiation was shielded.The ifu has pre-cautions for handling radiation.The device was returned to sirtex for investigation but the event was not replicated.The dhr review did not display any abnormal findings for the manufacturing process and all operations were completed per procedures.It was stated that the patient received their dose.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury should the full dose not be able to be administered.

• Brand Name: SIROS DELIVERY 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 drive; floor 2; woburn, MA 01801
• MDR Report Key: 22873186
• Report Number: 9710358-2025-00007
• Device Sequence Number: 10290806
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)220924(17)240924(10)10556133
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 09/24/2024
• Device Model Number: SIR-10300
• Device Lot Number: 10556133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• 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: 08/11/2023
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2022
• 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