MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (10 GBQ) CE MARK; MICROSPHERES RADIONUCLIDE

Model Number	2361-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: date of birth: (b)(6) 1967.A2: age at time of event: 56 years old at the time of study enrollment.D3 & g1: manufacturer address 1: chapman house, farnham bus park.D3 & g1: manufacturer zip/postal code: gu9 8ql.
Event or Problem Description
Proactif clinical study: it was reported that the patient had acute cholecystitis.Advanced, multicompartment dosimetry was performed to assess treatment dose.Pre-treatment macroaggregated albumin (maa) dosimetry documented, dose to total perfused liver as 346 gy.Dose to total perfused tumor was 402 gy.On (b)(6) 2023, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was selective for vials 1 and 2.The catheter was positioned in the right posterior sector (segments vi/vii).4.706 gbq of therasphere was administered to the selective liver through vial 1, and 2.564 gbq of therasphere was administered to the selective liver through vial 2, and total therasphere activity administered to the selective liver was 7.27 gbq.Post treatment dosimetry documented an uptake of the delivered dose; dose to total perfused liver was not determined and dose to the total perfused tumor was 424 gy.On (b)(6) 2023, on the same day of index procedure, the subject was diagnosed with acute cholecystitis.On (b)(6) 2023, 03 days post index procedure, the subject was hospitalized for further treatment and evaluation.Concomitant medication was given as a corrective action to treat the event.Symptomatic, medical intervention indicated.Hence, antibiotics started; ceftriaxone and metronidazole was given during the hospitalization period.On (b)(6) 2023, the subject was discharged from the hospital.From (b)(6) 2023, the medication was switched to 4g of piperacillin and 0.5g tazobactam and was stopped on (b)(6) 2023.On (b)(6) 2023, 34 days post index procedure during the follow up visit, the ecog performance assessment was performed, and the result was 1.Additionally, encephalopathy and ascites were assessed as 0.On (b)(6) 2023, 38 days post index procedure, the subject was re-diagnosed with acute cholecystitis.On (b)(6) 2023, 43, days post index procedure, the subject was hospitalized for further treatment and evaluation.Concomitant medication was given as a corrective action to treat the event.Symptomatic, medical intervention indicated.Antibiotics were administered during the hospitalization days.From (b)(6) 2023 the medication was switched to partazocilline (3 administration per day) and was stopped on (b)(6) 2023.On (b)(6) 2023, the subject was discharged from the hospital.

• Brand Name: THERASPHERE Y-90 (10 GBQ) CE MARK
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; 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: 21103490
• Report Number: 2124215-2024-83074
• Device Sequence Number: 15617649
• Product Code: NAW
• UDI-Device Identifier: 05060116920314
• UDI-Public: 05060116920314
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 2361-02
• Device Catalogue Number: 2361-02
• 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: 12/12/2024
• Initial Report FDA Received Date: 01/08/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG