MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Muscle Weakness (1967); Renal Failure (2041)

Event Date 01/28/2021

Event Type  Injury  

Event Description

(b)(6) study. It was reported that an infection occurred. In (b)(6) 2021, the subject was enrolled into the (b)(6) study and the treatment with therasphere was performed on the same day. The type of therasphere infusion was in the proper hepatic artery. 1. 2 gbq of therasphere was administered to the liver (selective) through vial 1 and 0. 3 gbq of therasphere was administered to the liver (selective) through vial 2. The total dose administered was 1. 5 gbq. Two days post index procedure, the subject was diagnosed with infection and acute renal failure. The subject had a body temperature of 39 degrees celsius and was positive for k. Pneumoniae and k. Oxytoca. The subject was treated medically. Five days post index procedure the events were considered resolved and the subject was discharged on the same day.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13015077
• MDR Text Key: 282386570
• Report Number: 2134265-2021-15874
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• 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: 12/15/2021 Patient Sequence Number: 1