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

Model Number	SIR-Y001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	02/08/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The treating physician does not believe that it was sir-spheres that caused the death.Sirtex conducted a review of batch rb006 and it was found to be a very typical batch; all activity measurements and qc test results were typical/acceptable and no non-conformances were raised.
Event or Problem Description
Sirtex's sales representative spoke with dr.Cho on friday, april 7 regarding an adverse event that occurred with a patient that was treated on (b)(6) 2023.Patient was prescribed 3.663 gbq's to segment 5 of the right lobe, tumor volume was 16cc's.Patient developed abdominal pain post treatment which progressed to further complications after the treatment.Patient died 5-6 weeks later from sepsis which originated in the anterior portion of the right lobe.

• 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: 300 unicorn park drive; floor 2; woburn, MA 01801 ; 7817213862
• MDR Report Key: 16875496
• Report Number: 9710358-2023-00002
• Device Sequence Number: 17957538
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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 Model Number: SIR-Y001
• Device Catalogue Number: SIR-Y001
• Device Lot Number: RB006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Sex: Unknown