MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (11 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	Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Nausea (1970); Pain (1994)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had nausea and pain that required prescription medication.The subject was enrolled into a clinical study on (b)(6) 2024.On (b)(6) 2024, the first treatment with therasphere was performed.On (b)(6) 2024, the second treatment with therasphere was performed.Therasphere was administered to the liver was selective (<=2 segments in the perfused volume) through femoral artery and one dose vial was administered; total administered activity dose was 3.84 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.On (b)(6) 2025, on the same day post second therasphere administration, the subject was noted with nausea, diarrhea, pain in the groin, and fatigue.The nausea was medically treated with ondansetron odt (zofran-odt) (4mg/oral/as needed, (b)(6) 2025).Pain in the groin was medically treated with ketorolac (toradol) (10mg/oral/as needed, from (b)(6) 2025).No action was taken to treat the events of diarrhea and fatigue.On (b)(6) 2025, seven days post second therasphere administration, the subject was noted with abdominal pain.No action was taken to treat this event.
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: 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 the patient had nausea and pain that required prescription medication.The subject was enrolled into a clinical study on (b)(6) 2024, the first treatment with therasphere was performed.On (b)(6) 2024, the second treatment with therasphere was performed.Therasphere was administered to the liver was selective (=2 segments in the perfused volume) through femoral artery and one dose vial was administered; total administered activity dose was 3.84 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.On (b)(6) 2025, on the same day post second therasphere administration, the subject was noted with nausea, diarrhea, pain in the groin, and fatigue.The nausea was medically treated with ondansetron odt (zofran-odt) (4mg/oral/as needed, (b)(6) 2025).Pain in the groin was medically treated with ketorolac (toradol) (10mg/oral/as needed, from (b)(6) 2025).No action was taken to treat the events of diarrhea and fatigue.On (b)(6) 2025, seven days post second therasphere administration, the subject was noted with abdominal pain.No action was taken to treat this event.It was further reported that on (b)(6) 2025, 30 days post second therasphere administration, the subject was noted with right upper quadrant pain.The subject was to be monitored.
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: (b)(6).G1: mfr site zip/post code: (b)(6).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
D3: manufacturer zip/postal code: 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 the patient had nausea and pain that required prescription medication.The subject was enrolled into a clinical study on (b)(6) 2024.On (b)(6) 2024, the first treatment with therasphere was performed.On (b)(6) 2024, the second treatment with therasphere was performed.Therasphere was administered to the liver was selective (<=2 segments in the perfused volume) through femoral artery and one dose vial was administered; total administered activity dose was 3.84 gbq.Post treatment dosimetry documented between random activity distribution and avid uptake in target lesion distribution of y90 on tumors.On (b)(6) 2025, on the same day post second therasphere administration, the subject was noted with nausea, diarrhea, pain in the groin, and fatigue.The nausea was medically treated with ondansetron odt (zofran-odt) (4mg/oral/as needed, on (b)(6) 2025).Pain in the groin was medically treated with ketorolac (toradol) (10mg/oral/as needed, from on (b)(6) 2025).No action was taken to treat the events of diarrhea and fatigue.On (b)(6) 2025, seven days post second therasphere administration, the subject was noted with abdominal pain.No action was taken to treat this event.It was further reported that on (b)(6) 2025, 30 days post second therasphere administration, the subject was noted with right upper quadrant pain.The subject was to be monitored.

• Brand Name: THERASPHERE Y-90 (11 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: 22099672
• Report Number: 2124215-2025-34383
• Device Sequence Number: 12598425
• Product Code: NAW
• UDI-Device Identifier: 05060116921533
• UDI-Public: (01)05060116921533
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2025

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: 2361-03
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 11/20/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/23/2025; 12/05/2025
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White