MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIROS DELIVERY SET; SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL

Model Number	SIR-10300
Medical Device Problem Codes	Complete Blockage (1094); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going and an update will be provided on the next report.
Event or Problem Description
The ir experienced unusual resistance when attempting to delivery the first aliquot of the dose.The dose stopped at the middle of the c-line and would not go any further.An attempt to "unclog" the delivery set was attempted but was unsuccessful.The decision was made to abort and reschedule as a second dose could not be drawn.It was stated that the patient was fine.
Additional Manufacturer Narrative
The initial mdr was filed out of an abundance of caution, so sirtex medical could learn the outcome of the patient's rescheduled treatment and to investigate the device for the potential of serious injury as the malfunction caused the patient's treatment to be rescheduled.Sirtex medical has learned that the patient was successfully treated on the rescheduled date, 97.3% of their dose was administered, and that the patient did well.Should a patient's treatment 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.This event is considered a malfunction because the device could not perform as intended however the malfunction did not cause or contribute to a change in the patient's condition that would be considered a reportable serious injury.The review of the batch record did not display anything abnormal for the manufacturing process and all operations were completed per procedures.No deviations or issues associated with the lot were found.Sirtex has made multiple attempts to obtain the device for further investigation, but the device has not been returned.Should the device be received by sirtex, a follow-up report will be provided after the investigation.
Event or Problem Description
The ir experienced unusual resistance when attempting to delivery the first aliquot of the dose.The dose stopped at the middle of the c-line and would not go any further.An attempt to "unclog" the delivery set was attempted but was unsuccessful.The decision was made to abort and reschedule as a second dose could not be drawn.It was stated that the patient was fine.

• 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: 23468698
• Report Number: 9710358-2025-00016
• Device Sequence Number: 15687305
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)250714(17)270714(10)11428101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/08/2025

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: 11428101
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2025
• 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