MAUDE Adverse Event Report: SIRTEX, WILMINGTON MA SIR-SPHERES MICROSPHERES; Y90 RESIN MICROSPHERES

Model Number	SIR-Y001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Sepsis (2067)
Date of Event	09/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent three sessions of tace and one session of y90.Routine imaging surveillance was performed following each therapy session.No significant changes to tumor size were noted.Development of abscess and sepsis within the treated tumor was seen.Following y90, patient underwent multiple percutaneous drainage procedures.Patient condition deteriorated and the family decided against further interventions.
Additional Manufacturer Narrative
Investigations could not be undertaken and conclusions could not be drawn due to lack of details related to the incident and the device used (no information was available/received on lot/batch number of device used or how the device was used).This adverse event was presented as part of a poster presentation at an ir conference with very limited information.Sirtex attempted to contact the person(s) alleging the incident but no response.No information was available/received about which healthcare provider or facility treated the patient.

• Brand Name: SIR-SPHERES MICROSPHERES
• Common Device Name: Y90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• Manufacturer Contact: 300 unicorn park; woburn, MA 01801 ; 7817213862
• MDR Report Key: 17996860
• Report Number: 3005579300-2023-00001
• Device Sequence Number: 5945408
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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
• 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: 09/25/2023
• Initial Report FDA Received Date: 10/24/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown