MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. SIROS D-VIAL PREP SET; SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL

Model Number	SIR-10200
Medical Device Problem Code	Emergency Power Failure (1205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the dose delivery, a leak was observed from the d-vial.Three aliquots of the dose were attempted and the patient received ~65% of the dose.The leak was contained within the d-vial holder and no contamination occurred.The pharmacy was called and provided a second dose and the second delivery was achieved with no further incident.
Additional Manufacturer Narrative
The investigation is on-going and an update will be provided on the next report.
Additional Manufacturer Narrative
There was no reported death or serious injury to the patient and they received their dose.Sirtex has learned that a new d-vial was used for the delivery of the second prepared dose.This mdr has been filed due to the potential for serious injury should the full dose not be able to be administered to the patient.A review of production records show the batch was manufactured to approved specifications and met all quality assurance criteria.Each unit is subject to a 100% leak test inspection per the supplier's procedure.The device was returned and functionally tested by sirtex.The event was not replicated as no leak was observed.Sirtex medical affairs has also stated from a medical perspective, this event does not represent a patient adverse event but rather a device-related malfunction without patient harm.The temporary under-delivery of dose was promptly recognized and mitigated, and there is no indication of increased safety risk or negative impact on patient outcome.The overall benefit/risk profile remains favorable, and no additional patient-level medical intervention or follow-up is warranted based on the information available.
Event or Problem Description
During the dose delivery, a leak was observed from the d-vial.Three aliquots of the dose were attempted and the patient received ~65% of the dose.The leak was contained within the d-vial holder and no contamination occurred.The pharmacy was called and provided a second dose and the second delivery was achieved with no further incident.

• Brand Name: SIROS D-VIAL PREP SET
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr.; 2nd fl.; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park; 2nd fl.; woburn, MA 01801
• MDR Report Key: 24022841
• Report Number: 3009088444-2026-00001
• Device Sequence Number: 18439468
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)250620(17)270620(10)1142842
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 1142842
• Was Device Available for Evaluation?: Yes
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown