MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. SIROS D-VIAL PREP SET; System, applicator, radionuclide, manual

Model Number	SIR-10200
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related death or serious injury was reported and it was stated that the patient was treated successfully.The ifu also states to ensure no air is in the lines.Sirtex performed interviews with the healthcare facility and the third-party pharmacy who prepared the dose.The suggested potential causes for the event of air in the d-vial after the dose preparation stage were: a less experienced team due to employee turnover at the third party pharmacy.Possibly air was becoming trapped in the valve and the third-party pharmacy did not ensure no air was in the device sirtex is working with the third-party pharmacy to resolve the issue.Sirtex medical affairs has stated, based on the available information, the reported air bubble within the delivery set via the d-vial requiring aspiration, along with localized syringe becoming radioactive, is most consistent with a preparation and handling-related issue rather than an intrinsic device malfunction.The procedure was completed successfully without patient injury or clinical sequelae, supporting that there was no meaningful impact to patient safety or treatment delivery.The observed findings align with known procedural risks associated with system priming and handling of radioactive material, as described in the ifu.While the risk to the operator appears minimal and self-limited, the recurrence at the same site suggests the need for reinforcement of proper preparation and verification steps.Overall, the benefit-risk profile of the device remains unchanged.
Event or Problem Description
A complaint was received stating multiple occasions of air being introduced to the delivery set via the prepared dose from the d-vial.The dose is prepared by a third party pharmacy which is then provided to the hospital.

• 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 drive; 2nd fl.; woburn, MA 01801
• MDR Report Key: 24967087
• Report Number: 9710358-2026-00012
• Device Sequence Number: 10496198
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: 00850014612016
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 04/23/2026

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
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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