MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (4.5 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE

Model Number 2361-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low White Blood Cell Count (4433)

Event Date 12/20/2021

Event Type  Injury  

Event Description

(b)(6) study. It was reported decreased lymphocyte count occurred. In (b)(6) 2021 the subject was enrolled into the (b)(6) study. Two weeks later treatment with therasphere was performed; the planned treatment type was selective treatment. Total programmed calculation of dose to perfused target liver tissue was 431. 03 gy. Four days post index procedure, the subject was diagnosed with lymphocyte count decreased with nci-ctcae v5. 0 grade as grade 3 (severe). No action was taken to treat the event. At the time of reporting, the outcome of the event was unknown.

• Brand Name: THERASPHERE Y-90 (4.5 GBQ) CN CLINICAL
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house; weydon lane; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house; weydon lane; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13267273
• MDR Text Key: 283944589
• Report Number: 2134265-2022-00228
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 2361-01
• Device Catalogue Number: 2361-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/17/2022 Patient Sequence Number: 1