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 Code	Nausea (1970)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer address 1: (b)(6).D3: manufacturer zip/postal code: (b)(6).G1: mfr site address 1: (b)(6).G1: mfr site zip/post code: (b)(6).
Event or Problem Description
(b)(4) trial.It was reported that nausea occurred requiring prescription medication.On (b)(6)2024, the subject received a third administration of study treatment, therasphere.Pre-treatment (macro aggregated albumin) maa imaging documented a significantly higher perfusion of maa on tumors.Lung shunt calculation was (b)(4).Therasphere administered to the liver was multiple selective, similar (=1cm) through femoral artery, and 3 dose vials were administered.On (b)(6) 2024, same day post third therasphere administration, the subject was noted with nausea.Subject received treatment with zofran (4mg/as needed) as corrective treatment for the event.

• Brand Name: THERASPHERE Y-90 (3 GBQ) US
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20518033
• Report Number: 2124215-2024-66483
• Device Sequence Number: 8855993
• Product Code: NAW
• UDI-Device Identifier: 05060116921373
• UDI-Public: 05060116921373
• 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: 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): 10/23/2024

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: 09/26/2024
• Initial Report FDA Received Date: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White