MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIR-SPHERES MICROSPHERES; Y90 RESIN MICROSPHERES

Model Number	SIR-Y002
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sirtex followed up with the physician and was told the "patient stayed overnight and was in some pain" and no other details were provided.Pain is an expected adverse event listed in the ifu.Sirtex medical affairs has stated that stasis is a procedural complication and could be considered an adverse event should the patient be under dosed.It was also stated that stasis most commonly occurs due to the patient's physiology.Batch record review showed the device was manufactured to released specifications and had passing quality test results.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury should the full dose not be able to be administered.
Event or Problem Description
Physician reached stasis unexpectedly.The patient stayed overnight and was in some pain.

• Brand Name: SIR-SPHERES MICROSPHERES
• Common Device Name: Y90 RESIN MICROSPHERES
• 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: 22873954
• Report Number: 3005579300-2025-00018
• Device Sequence Number: 10371184
• Product Code: NAW
• UDI-Device Identifier: 00850014612146
• UDI-Public: (01)00850014612146(11)241117(17)241123(10)SK032
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2024
• Device Model Number: SIR-Y002
• Device Lot Number: SK032
• 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: 11/20/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown