MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (3.5 GBQ) CE MARK; MICROSPHERES RADIONUCLIDE

Model Number	2361-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced hepatic dysfunction post therasphere administration.A therasphere y-90 (3.0 gbq) dose vial and a therasphere y-90 (3.5 gbq) was selected for use in the radioembolization procedure.The patient was being treated for hepatocellular carcinoma (hcc).This was a bilobar treatment.The was noted to be multifocal with a total tumor volume of 29.3ml.There was nothing unusual observed during device preparation or the therasphere procedure.Following therasphere administration, liver function tests (lfts) revealed that the patient was experiencing hepatic dysfunction.As a result, the patient was administered reild prophylaxis (prednisolone 10 mg/d, udc 500 mg bid, lwh).There were no further patient complications.
Additional Manufacturer Narrative
Based on the nature of this product, we are unable to provide the complete unique identifier (udi) and other product specific information.

• Brand Name: THERASPHERE Y-90 (3.5 GBQ) CE MARK
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22917753
• Report Number: 2124215-2025-60202
• Device Sequence Number: 9878519
• Product Code: NAW
• UDI-Device Identifier: 05060116920345
• UDI-Public: (01)05060116920345
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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 Model Number: 2361-02
• Device Catalogue Number: 2361-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THERASPHERE Y-90 (3 GBQ)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown