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

Model Number	SIR-10300
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A retrospective mdr has been filed due to the potential for serious injury.The physician stated that the patient might have to come back to fully treat the tumor.The device was returned to sirtex for investigation but the event was not replicated.The batch record review did not display any abnormal findings for the manufacturing process and all operations were completed per procedures.
Event or Problem Description
3 dose split - 3 gbq (10.8mci-.4 gbq, 13.5 mci-.5 gbq and 24.3mci-.9 gbq) draw was done by jubilant radiopharmacy on (b)(6) 2024.First dose administered by the physicians (actually pushed on the d line) got about 1ml in and then moved to b line to follow with straight contrast run (she knows we recommend 50/50, we discussed).Physician went back to the d line and tried to push felt resistance and sir-spheres started to come out of the d-vial.We stopped immediately and assessed the situation.We made sure all lines were tight/hooked up properly (as they were went step by step in the beginning), discussed a possible kinked catheter or sheath that could kink catheter, but physician did not feel that was the case.We were in distal vessels and at the time we were treating segment 5 with this 10.8mci dose.Physician then bagged up everything (siros, delivery tubing, d-vial and catheter) and sent to nuclear medicine to measure.Reading was high, but was not a direct comparison in the beginning no nalgene bottle/acrylic bottles used just the dose sitting seated in siros unit and tubing wrapped up.Physician wanted to pull another dose, based on what was delivered, but was unable to get an accurate reading with jubilant gone for the day as the case started late.Discussion were had to trouble shoot.Physician treated the other two tumors in segment 5 and 8 and left this one alone since they did not safely know how much was actually delivered in 1ml and jubilant was gone.Physician used 50/50 contract on the last two deliveries - b line.Delivered two other doses with 94% delivered and successfully completed the case around 6/6:15pm cst on (b)(6).Patient was not harmed and doctor planned to reassess bringing the patient back to treat the first tumor.Few things to consider they ran out of 10cc/20cc syringes so the 2 and 3rd to doses were delivered with a 30cc.Wire used: fatham wire180cm, trueselect (boston sci) was the micro cath.021, 155c, verse normal 120cm because of product availability.(b)(6) 2024 spoke to jubilant and they stated nothing felt off during the dose draw and got it on second attempt even with a small dose of 10.8mci.Jubilant pulled 3% higher on the 10.8mci and 6 % higher on the 13.5 mci and.8% higher on the 24.3 mci.The trash bag with contaminated goods is sitting in nuclear med decaying and requested them to hang onto as i will send back to the company for investigation.

• 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, 2nd floor; woburn, MA 01801
• MDR Report Key: 22873375
• Report Number: 3005579300-2025-00011
• Device Sequence Number: 18738516
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)230821(17)250821(10)1109070
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2025
• Device Model Number: SIR-10300
• Device Lot Number: 1109070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• 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: 01/08/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Female