MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (9.5 GBQ); MICROSPHERES RADIONUCLIDE

Model Number	2361-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ascites (2596)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was hospitalized for treatment of ascites.On (b)(6) 2022, the subject was enrolled into the proactif study and the treatment with therasphere to the right liver was performed on the same day.The catheter was positioned in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii), and 3.55 gbq of therasphere was administered through vial 1.The dose to total perfused tumor was 213.4 gy.On an unknown date in (b)(6) 2022, the subject was diagnosed with ascitic decompensation.The subject was hospitalized and treated with furosemide 60 and aldactone 100.The patient had been discharged from the hospital and the issue was considered resolved.The patient had been discharged from the hospital and the issue was considered resolved.
Additional Manufacturer Narrative
D3: manufacturer address 1: chapman house, farnham bus park d3: manufacturer zip/postal code: gu9 8ql g1: mfr site address 1: chapman house, farnham bus park g1: mfr site zip/post code: gu9 8ql.
Additional Manufacturer Narrative
Correction to field d4: model/catalog and serial number.D3: manufacturer address 1: chapman house, farnham bus park.D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site zip/post code: gu9 8ql.
Event or Problem Description
It was reported that this patient was hospitalized for treatment of ascites.On (b)(6) 2022, the subject was enrolled into the proactif study and the treatment with thermosphere to the right liver was performed on the same day.The catheter was positioned in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii), and 3.55 gbq of thermosphere was administered through vial 1.The dose to total perfused tumor was 213.4 gy.On an unknown date on (b)(6) 2022, the subject was diagnosed with ascitic decompensation.The subject was hospitalized and treated with furosemide 60 and aldactone 100.The patient had been discharged from the hospital and the issue was considered resolved.The patient had been discharged from the hospital and the issue was considered resolved.

• Brand Name: THERASPHERE Y-90 (9.5 GBQ)
• 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: 18334260
• Report Number: 2124215-2023-70462
• Device Sequence Number: 12461869
• Product Code: NAW
• UDI-Device Identifier: 05060116920444
• UDI-Public: 05060116920444
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 2361-02
• Device Catalogue Number: 2361-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG