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U.S. Department of Health and Human Services

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

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BWXT 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 Abdominal Pain (1685); Fatigue (1849); Hyperbilirubinemia (1903); Nausea (1970); Stenosis (2263); Decreased Appetite (4569)
Event Date 09/30/2019
Event Type  Injury  
Manufacturer Narrative
Bibok, andras, et al. "role of radioembolization in the management of liver-dominant metastatic renal cell carcinoma: a single-center, retrospective study. " cardiovascular and interventional radiology 44. 11 (2021): 1755-1762. Date of event was approximated using month of article publication.
 
Event Description
It was reported via journal article that patient complications occurred. This is a retrospective, single-center study. Thirty-eight patients' medical records were reviewed who underwent tare between january l, 2009, and december 31, 2019, in a tertiary cancer center. Two were excluded from further analysis. Thirty-six patients received 51 tare treatments. The y-90 therasphere was referenced in the study. The 30-day mortality rate was 0%. Mild (ctcae grade 1-2) clinical toxicities were reported by 22 patients: fatigue (n
=
17), nausea (n
=
5), abdominal pain (n
=
4), and decreased appetite (n
=
2). Two patients presented with grade 3 biliary strictures 3 and 8 months after tare, which were not related to tumor progression and were attributed to the tare treatment.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BWXT
447 march road
kanata, on k2k 1x8
CA
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 Key13000803
MDR Text Key282204553
Report Number2134265-2021-15139
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
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 Received11/17/2021
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: 12/14/2021 Patient Sequence Number: 1
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