MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIROS DELIVERY SET; System, applicator, radionuclide, manual

Model Number	SIR-10300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event involved no death or serious injury to the patient and the patient received their dose.The device was returned to sirtex and the broken/cracked piece was observed.A batch record review was performed and no abnormalities were observed during the manufacture of the batch.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury if under dosing occur due to pressure/leakage.
Event or Problem Description
Luer-lock connection on d line cracked and broke off.As the doctor was finishing administration of sir-spheres, the outer portion of the luer-lock of the d line connection going into the d-vial, cracked and a piece flew across the inside of the siros box.At this point, 30 ml of d5 had already been administered through the d line, and 30 ml of 50/50 through the b line.The doctor was still able to administer an additional 10-15 ml of 50/50 through the b line and contrast flowed through the progreat microcatheter without a problem.Visual inspection of d/c line was done and no clumping of particles were seen.The doctor did not feel it was safe to continue administration through the d line with fear of building up additional pressure within the system.The case was completed at this time.Preliminary survey showed less than 5% residual left of the dose and no detection of radiation leakage within the siros dome.Thoughts are either a defective/thin plastic on the luer-lock area or when the d line connections were attached, that this was possibly done too tight.System was labeled to save for return to sirtex if they would like to assess the system.

• 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; floor 2; woburn, MA 01801
• MDR Report Key: 22873518
• Report Number: 3005579300-2025-00013
• Device Sequence Number: 5776137
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)230720(17)250720(10)1109079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/22/2025

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 Expiration Date: 07/20/2025
• Device Model Number: SIR-10300
• Device Lot Number: 1109079
• 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: 06/11/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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