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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BWXT Y-90 THERASPHERE (10.5 GBQ) EUROPE MICROSPHERES RADIONUCLIDE

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BWXT Y-90 THERASPHERE (10.5 GBQ) EUROPE MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Inflammation (1932)
Event Date 02/15/2022
Event Type  Injury  
Event Description
It was reported that this patient was hospitalized and treated for inflammation of the lung. Y-90 therasphere therapy was selected to treat cancer in the right lobe of the liver of this patient. The tc-99m macroaggregated albumin (maa) screening performed prior to the therasphere treatment indicated the patient had a lung shunt fraction of 13. 7%. Four vials were ordered for this patient; 10gbq, 10. 5gbq and two 20gbq. In the second week, y-90 therasphere 10. 5gbq vial was used to treat the tumor with the target volume of 243. 1cc. The other three vials were used to treat the tumor with the target volume of 1128. 7cc. Approximately two months after treatment, the patient was admitted to the hospital with symptoms of shortness of breath. An magnetic resonance imaging (mri) was performed that showed inflammation of the lung, and the patient was treated with a high dose of steroids for two weeks. The patient was discharged from the hospital and continued to improve.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameY-90 THERASPHERE (10.5 GBQ) EUROPE
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BWXT
447 march road
kanata K2K 1 X8
CA K2K 1X8
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
weydon lane, farnham
surrey
UK
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13774455
MDR Text Key287584444
Report Number2134265-2022-02868
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2361-02
Device Catalogue Number2361-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
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: 03/15/2022 Patient Sequence Number: 1
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