MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (8.5 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 Codes	Abdominal Pain (1685); High Blood Pressure/ Hypertension (1908); Vomiting (2144); Unintended Radiation Exposure (4565)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced abdominal pain and vomiting requiring prescription medication as a result of the therasphere procedure.The patient was being treated for uveal melanoma.A therasphere y-90 (8.5 gbq) dose vial was selected for use in the radioembolization procedure.The multifocal, small lesions were located in the bilobar liver.The total tumor volume was approximately 7.4ml.There was nothing unusual observed during device preparation or the therasphere procedure.Post procedure imaging revealed the expected accumulation of microspheres within the liver, as well as accumulation within the area of the gallbladder.Following the therasphere procedure, the patient experienced transitory upper abdominal pain, vomiting, and a hypertensive crisis.To treat the pain and vomiting, the patient was administered novalgin and odansetron (zofran).The patient was also administered antibiotic cholecystitis prophylaxis with unacid.The pain was reported to have resolved after one day.There was no reported intervention for the hypertensive crisis.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 (8.5 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: 22916931
• Report Number: 2124215-2025-60209
• Device Sequence Number: 9919897
• Product Code: NAW
• UDI-Device Identifier: 05060116920420
• UDI-Public: (01)05060116920420
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown