MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (5.5 GBQ) US; MICROSPHERES RADIONUCLIDE

Model Number	2361-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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Event or Problem Description
It was reported that misadministration occurred, requiring prescription medication.A 5.5 gbq dose vial of therasphere microspheres was ordered to treat the liver.Prior to therasphere administration, the patient underwent pre-emptive embolization of the gastroduodenal artery (gda) and right gastric artery.Following therasphere administration to the left hepatic lobe, imaging revealed a focus of activity over the lesser curvature of the stomach.The patient was started on a proton pump inhibitor (2x per day) and sucralfate with plans for an esophagogastroduodenoscopy (egd) in 2-3 weeks.There were no further patient complications as a result of this event.

• Brand Name: THERASPHERE Y-90 (5.5 GBQ) US
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; UK 55112 ; 6512422111
• MDR Report Key: 24469160
• Report Number: 2124215-2026-10951
• Device Sequence Number: 10277962
• Product Code: NAW
• UDI-Device Identifier: 05060116921427
• UDI-Public: (01)05060116921427
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 2361-03
• Device Catalogue Number: 2361-03
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/27/2026
• 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 Age: 72 YR
• Patient Sex: Unknown