MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (7.5 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	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an allergic reaction occurred post-therasphere administration.The patient was treated with therasphere on (b)(6) 2024, delivered to the right hepatic.Approximately a week after treatment, the patient experienced full body hives that would last a few hours and would come and go.It was noted that the patient did not have any non-target radiation exposure or shunting to tissues near the skin.The patient did not have any known allergies to glass, metals, contrast, medications, or products.The patient also had no change in their current chemo medication regimen.Treatment for the hives was conservative with benadryl and prednisone, and the symptoms had significantly subsided at the time of this report.
Additional Manufacturer Narrative
D3 & g1: manufacturer zip/postal code: (b)(6).

• Brand Name: THERASPHERE Y-90 (7.5 GBQ) US
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; 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: 19059701
• Report Number: 2124215-2024-21065
• Device Sequence Number: 5897616
• Product Code: NAW
• UDI-Device Identifier: 05060116921465
• UDI-Public: 05060116921465
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/08/2024

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: 2499093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/08/2024
• 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: Required Intervention
• Patient Sex: Male