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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 Problem Low White Blood Cell Count (4433)
Event Date 08/20/2015
Event Type  Injury  
Manufacturer Narrative
Li, xi, et.Al., prognostic significance of neutrophil to lymphocyte ratio dynamics in patients with hepatocellular carcinoma treated with radioembolization using glass microspheres, european journal of nuclear medicine and molecular imaging, 2020.Ttps://doi.Org/10.1007/s00259-020-05186-y.Date of event: patient treatments occurred from august 20, 2015 and may 24, 2019.
 
Event Description
It was reported via literature article that lymphopenia occurred.A retrospective, single-center review of clinical records and treatment parameters (liver volume treated, administered activity, and radiation dose) in consecutive patients who received radioembolization for hcc was performed between august 20, 2015, and may 24, 2019.One hundred sixty-three patients with a median 67.0 years of age were included for analysis.Analysis found a decrease in lymphocyte count was found after radioembolization in 154 patients (94.5%).Only one patient had a severe lymphopenia < 0.2x109/l.In conclusion, neutrophil to lymphocyte ratio was not predictive of overall survival.
 
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Brand Name
Y-90 THERASPHERE (3 GBQ) CANADA COMM
Type of Device
MICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus park
weydon lane
farnham, surrey GU9 8 QL
UK  GU9 8QL
MDR Report Key12097240
MDR Text Key259360378
Report Number2134265-2021-07865
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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