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

Model Number	SIR-Y002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Gastritis (1874); Nausea (1970); Pain (1994)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Non-target delivery of sir-spheres microspheres resulting in gastritis is a recognized potential complication/adverse event of this therapy.A comprehensive device history record review was performed for this product batch and did not result in any abnormal findings related to the manufacturing process.There is no evidence to suggest that the device malfunctioned or was not used as intended.We have reached out to the treating physician for additional information and will provide an update if/when this information becomes available.
Event or Problem Description
Post procedure imaging showed that a significant portion of the treating dose was delivered to patient's spleen and stomach.Patient experienced nausea and pain after the procedure.Patient is doing well now.

• 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: vana poovala ; 300 unicorn park drive; floor 2; woburn, MA 01801 ; 7817213862
• MDR Report Key: 21183722
• Report Number: 9710358-2025-00001
• Device Sequence Number: 8537189
• Product Code: NAW
• UDI-Device Identifier: 00850014612146
• UDI-Public: (01)00850014612146(11)241201(17)241207(10)SL003V01
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

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: 12/07/2024
• Device Model Number: SIR-Y002
• Device Lot Number: SL003
• 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: 12/20/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female