MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (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 Code	Unintended Radiation Exposure (4565)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that non-target radiation exposure occurred.A 5 gbq therasphere dose vial was selected for use in a y-90 procedure.There were no issues during administration.However, post administration imaging results revealed radiation in the stomach.It is believed that there was shunting that was not seen during post (macroaggregated albumin) maa imaging.97.7% of the vial was delivered at the time of administration.The target tissue received 0.504gbq (86.9%), the stomach wall received 0.056gbq (9.6%), and the lungs received 0.022gbq (3.8%).As a result, the patient was given prophylactic antibiotics.No patient complications were reported.

• Brand Name: THERASPHERE Y-90 (5 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: 19515542
• Report Number: 2124215-2024-33041
• Device Sequence Number: 12610580
• Product Code: NAW
• UDI-Device Identifier: 05060116921410
• UDI-Public: 05060116921410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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
• Device Lot Number: 2499217
• 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: 05/14/2024
• Initial Report FDA Received Date: 06/11/2024
• 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 Sex: Unknown