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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fistula (1862)
Event Date 06/01/2021
Event Type  Injury  
Event Description
It was reported via journal article a fistula occurred. The article reviewed a patient who underwent transarterial radioembolization (tare) with y-90 therasphere glass microspheres to segments 5 and 6. A total of 4. 56 gbq was administered on tuesday of week i calibration. Target dose was 250 gy for a perfused volume of 850 ml. At the 3 month follow up, magnetic resonance imaging demonstrated complete response, with no signs of complications. However, at the 6 month follow up, unenhanced computed tomography (ct) showed a biloma in the radioembolization zone and a drainage tube was placed. Injection of the drain showed a fistula to the small bowel. A ct was performed after injection of the biloma drain, demonstrating a fistulous communication with both the small bowel and the biliary tree. A plastic stent was placed by endoscopic retrograde cholangiopancreatography; however, i month later, the endoscopically placed stent was dislodged and had migrated into the bilioenteric fistula. The dislodged stent was subsequently removed and replaced with a biliary drainage catheter. Five months since its initial placement, the drain has remained in place, with continued bilious output and persistence of the small bowel fistula.
 
Manufacturer Narrative
Journal article: https://doi. Org/10. 1016/j. Jvir. 2021. 06. 013. Date of event: the date of event is not specified therefore the date of the article submission was used.
 
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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
UK
Manufacturer Contact
johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13006541
MDR Text Key282275203
Report Number2134265-2021-15757
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,Health Professional,Company Representative
Reporter Occupation
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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