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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE Back to Search Results
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.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES 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 Key13015077
MDR Text Key282386570
Report Number2134265-2021-15874
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
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 Received12/15/2021
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 Received01/17/2022
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
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