MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (3 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); Heartburn/Indigestion (1883); Liver Damage/Dysfunction (1954)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer zip/postal code: (b)(6), g1: mfr site zip/post code: (b)(6).The lot number was not provided by the study; thus, the udi and other product specific information are unavailable.
Event or Problem Description
It was reported that the patient had abdominal pain, requiring prescription medication.The subject was enrolled into a clinical study on (b)(6) 2024.Pre-treatment macroaggregated albumin (maa) imaging documented a significantly higher perfusion of maa on tumors, dose to perfused liver was 400 gy; dose to total normal tissue was 20 gy.Lung shunt calculation was 17%.Therasphere treatment administration was performed on (b)(6) 2024.Therasphere administered to the liver was multiple selective through the femoral artery and two dose vials were administered; total administered activity dose was 1.611gbq.Post treatment dosimetry documented avid uptake in target lesion distribution of y90 on tumors.Dose to perfused liver was 1270 gy; dose to total normal tissue was 57 gy.Lung dose calculation was 0.On (b)(6) 2024, same day post index procedure, subject was noted with abdominal pain that radiates to back and dyspepsia.The pain was treated medically with oxycodone (5 mg/oral/as needed).Dyspepsia was treated with pantoprazole.On (b)(6) 2024, 40 days post index procedure, subject was diagnosed with elevated gamma-glutamyl transferase (ggt).No action was taken to treat this event.

• Brand Name: THERASPHERE Y-90 (3 GBQ) US
• 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 ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21884072
• Report Number: 2124215-2025-24808
• Device Sequence Number: 19715449
• Product Code: NAW
• UDI-Device Identifier: 05060116921373
• UDI-Public: (01)05060116921373
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 04/22/2025

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: 03/25/2025
• Initial Report FDA Received Date: 04/22/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 57 KG