MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (5 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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vomiting (2144)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - date of birth: the subject's birth year was reported as 1944.D3 & g1: (b)(4).
Event or Problem Description
The subject was enrolled in the immuwhy investigator-initiated study (iis) with patient identifier (b)(6).It was reported that the subject experienced esophageal varices hemorrhage.The subject was hospitalized, and intervention was performed as a result.On (b)(6) 2023, the subject was treated with 5 gbq of therasphere y-90 glass microspheres.On (b)(6) 2023, the subject was admitted to hospital for esophageal varices hemorrhage with secondary symptom hematemesis.To treat the event, rubber band ligation was placed.The event was considered to be ongoing.
Additional Manufacturer Narrative
A2 - date of birth: the subject's birth year was reported as 1944.D3 & g1 - manufacturer address 1: chapman house, farnham bus park.D3 & g1 - manufacturer zip/postal code: gu9 8ql.E1 initial reporter phone: (b)(6).
Event or Problem Description
Immuwhy pat 015-004.It was reported that the subject experienced esophageal varices hemorrhage.The subject was hospitalized, and intervention was performed as a result.On (b)(6) 2023, the subject was treated with 5 gbq of therasphere y-90 glass microspheres.On (b)(6) 2023, the subject was admitted to hospital for esophageal varices hemorrhage with secondary symptom hematemesis.To treat the event, rubber band ligation was placed.The event was considered to be ongoing.It was further reported that the event was considered resolved on (b)(6) 2023.

• Brand Name: THERASPHERE Y-90 (5 GBQ) CE MARK
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK (TS); weydon lane, farnham; surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18163970
• Report Number: 2124215-2023-64134
• Device Sequence Number: 15079022
• Product Code: NAW
• UDI-Device Identifier: 05060116920291
• UDI-Public: 05060116920291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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
• Device Lot Number: 2399355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/14/2023
• 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: Female
• Patient Weight: 72 KG