MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (16.5 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	Inflammation (1932); Nausea (1970); Ulcer (2274)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced nausea requiring prescription medication that was causal to the therasphere device.The subject was enrolled into the study on 03-jan-2025.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 5.45 %.On (b)(6) 2025, the treatment with therasphere was performed.Therasphere was administered to the lobar and selective(s) through femoral artery.3 dose vials were administered.Total administered activity was 4.17 gbq.Post treatment dosimetry documented avid uptake in all lesions.Lung dose calculation was 11.4.On (b)(6) 2025, 2 days following therasphere administration, the subject was noted with nausea.The nausea was medically treated with prochlorperazine (compazine) (10 mg/oral/every 6 hours as needed).No action was taken with regards to the study treatment.
Additional Manufacturer Narrative
A2 - age at time of event: the patient was 77 years old at the time of study enrollment.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 the patient experienced nausea requiring prescription medication that was causal to the therasphere device.The subject was enrolled into the study on (b)(6) 2025.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was 5.45 %.On (b)(6) 2025, the treatment with therasphere was performed.Therasphere was administered to the lobar and selective(s) through femoral artery.3 dose vials were administered.Total administered activity was 4.17 gbq.Post treatment dosimetry documented avid uptake in all lesions.Lung dose calculation was 11.4.On (b)(6) 2025, 2 days following therasphere administration, the subject was noted with nausea.The nausea was medically treated with prochlorperazine (compazine) (10 mg/oral/every 6 hours as needed).No action was taken with regards to the study treatment.It was further reported that on (b)(6) 2025, 43 days post the therasphere administration the subject was noted with duodenitis and duodenal ulcers.Duodenitis was medically treated with bismuth subsalicylate (524mg/four times a day) and duodenal ulcers were treated with tetracycline (500 mg/four times a day).
Additional Manufacturer Narrative
A2 - age at time of event: the patient was 77 years old at the time of study enrollment.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.Investigation results: labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the therasphere device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: THERASPHERE Y-90 (16.5 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 23490814
• Report Number: 2124215-2025-79889
• Device Sequence Number: 17301289
• Product Code: NAW
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 05/07/2026
• 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: 77 YR
• Patient Sex: Male