MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (6.5 GBQ) US; MICROSPHERES RADIONUCLIDE

Model Number	2361-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Unintended Radiation Exposure (4565); Decreased Appetite (4569)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that radiation to an unintended location occurred, requiring hospitalization.A case for therasphere treatment in the left lobe was performed.The case went as planned.A few hours later, however, post-imaging had showed that there was radiation occurred to the stomach and only about 30% was delivered to the target location.The patient was admitted to the hospital beyond the standard of care.The patient was discharged the next day and was being closely monitored.
Additional Manufacturer Narrative
D3, manufacturer zip/postal: gu9 8ql.G1, mfr site zip/post code: gu9 8ql.Based on the nature of this product, we are unable to provide the complete unique identifier (udi) and other product specific information.
Additional Manufacturer Narrative
H6, patient codes added.H6, impact codes added.D3, manufacturer zip/postal: gu9 8ql.G1, mfr site zip/post code: gu9 8ql.Based on the nature of this product, we are unable to provide the complete unique identifier (udi) and other product specific information.
Event or Problem Description
It was reported that radiation to an unintended location occurred, requiring hospitalization.A case for therasphere treatment in the left lobe was performed.The case went as planned.A few hours later, however, post-imaging had showed that there was radiation occurred to the stomach and only about 30% was delivered to the target location.The patient was admitted to the hospital beyond the standard of care.The patient was discharged the next day and was being closely monitored.It was further reported that approximately 2 hours post-administration (after the patient had been discharged), nuclear medicine physicians evaluating the spect/ct results notified the prescribing physician of abnormal uptake into the stomach wall and to a lesser extent the upper left quadrant (not organ-specific).Retrospective review (with enhancement) of dsa showed a possible small accessory right gastric artery branch that potentially provided a path for extrahepatic distribution of the y-90 microspheres, though it is diminutive in size relative to the left hepatic artery and its branches (and was not expected to contribute to extraheptic uptake).However, this was not observable on the initial dsa (without enhancement).Initial estimates of the extrahepatic uptake were approximately 70 percent of the administered dose.The patient noted fatigue, decreased appetite, and some left upper quadrant pain.The patient returned to the emergency department (ed) for examination.In the ed, the prescribing physician discussed plans for monitoring, administering a proton-pump inhibitor and sucralfate (pepto) to ameliorate any developing gastritis, recommended avoiding non-steroidal anti-inflammatory drugs (nsaid), and instructed to return to the ed if any food intolerance (because the patient hadn't eaten since before the procedure) or worsening abdominal pain.The prescribing physician made arrangements to repeat spect/ct imaging at day 3 post-administration to confirm distribution of the microspheres and help determine the percentages distributed intra-hepatically and extrahepatically.

• Brand Name: THERASPHERE Y-90 (6.5 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24103089
• Report Number: 2124215-2026-03310
• Device Sequence Number: 21397233
• Product Code: NAW
• UDI-Device Identifier: 05060116921441
• UDI-Public: (01)05060116921441
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement 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: Hospitalization
• Patient Sex: Unknown