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	04/24/2026
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 is working with the third party pharmacy to resolve the issue.Sirtex medical affairs has assessed this event as most consistent with a preparation and handling-related issue associated with third-party pharmacy dose preparation rather than an intrinsic malfunction of the siros d-vial prep set.The procedure was completed successfully with no reported patient injury, adverse clinical sequelae, or meaningful impact to treatment delivery.The reported presence of air within the line is a known handling consideration addressed within the ifu, and the recurrence at the same site supports reinforcement of proper preparation and priming procedures.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.The hospital used a syringe to remove the air bubble and became radioactive.

• Brand Name: SIROS D-VIAL PREP SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr.; fl. 2; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park; fl. 2; woburn, MA 01801
• MDR Report Key: 25279018
• Report Number: 3005579300-2026-00001
• Device Sequence Number: 9777278
• 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): 05/26/2026

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: 04/27/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown