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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES LTD. Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 01/01/2019
Event Type  Death  
Manufacturer Narrative
Journal article: jia, zhongzhi, and weiping wang. "hepatic necrosis following yttrium-90 radioembolization for hepatocellular carcinoma in a patient with a recent history of external radiotherapy. " journal of cancer research and therapeutics 17. 4 (2021): 1104. Date of death, date of event, implant date: dates were approximated based on month of article submission.
 
Event Description
It was reported via a journal article that patient complications occurred. At 55 days after 90 y treatment, a repeat contrast enhanced ct scan demonstrated a new low attenuation lesion in the right lobe, in addition to the irregularly shaped low attenuation lesions at the dome. Mri confirmed the presence of this new low attenuation lesion, and mr results suggested that this lesion was liquid in nature. Because the patient's symptoms were worsening, she agreed to have a percutaneous drain placed, and a 10 fr pigtail catheter was inserted into the new low-attenuation lesion. When the catheter was injected, the contrast material was seen in the low-attenuation lesions at the dome via multiple connections from the cavity. A total of 30 ml of necrotic material was aspirated during the procedure, but the cultures of this material were negative. After drain placement, the output gradually transitioned to pure bile, with a daily output of approximately 80-120 ml. The biloma cavity eventually resolved over the next 5 weeks of external drainage, and the drain was converted to an internal/external biliary drain. The catheter was capped to internal drainage with the intention of possibly removing the catheter if clinical stability was documented. Unfortunately, the patient's overall condition continued to deteriorate as the disease progressed, and she died 6 months after 90y treatment.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES LTD.
chapman house, farnham bus prk
weydon lane
farnham, surrey
UK
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 Key12994489
MDR Text Key282179480
Report Number2134265-2021-15151
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/13/2021
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
Device Model Number2361-01
Device Catalogue Number2361-01
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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