• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (12.5 GBQ) CE MARK MICROSPHERES RADIONUCLIDE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (12.5 GBQ) CE MARK MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pleural Effusion (2010); Ascites (2596); Liver Failure (4492); Swelling/ Edema (4577)
Event Date 06/22/2021
Event Type  Death  
Manufacturer Narrative
Date of birth: patient was born in (b)(6). Manufacturer address: (b)(4). Mfr site address: (b)(4). Initial reporter address 1: (b)(6).
 
Event Description
It was reported that patient death occurred following a therasphere procedure. Standard single compartment dosimetry was performed to assess treatment dose. Pretreatment maa imaging documented a strong uptake of maa on tumors, doses to perfused liver was 135. 9 gy, dose to perfused tumor was 278 gy. On (b)(6) 2021 the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day. 12. 5 gbq was administered to the right liver through vial 1. On (b)(6) 2021, the subject was hospitalized for edema-ascitic decompensation. On (b)(6) 2021, subject diagnosed with right pleural effusion of great abundance and left basal ventilatory disorder. A thoraco-abdomino-pelvic scan was performed. On (b)(6) 2021, subject diagnosed with stable high abundance ascites. On (b)(6) 2021, subject was discharged from hospital. On the infectious level: biological inflammatory syndrome probably linked to post-embolization tumor necrosis with risk of superinfection. On (b)(6) 2021, subject passed away.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHERASPHERE Y-90 (12.5 GBQ) CE MARK
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
surrey GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
surrey GU9 8 QL
UK GU9 8QL
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13957390
MDR Text Key288266494
Report Number2134265-2022-03649
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
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 Received03/03/2022
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: 03/30/2022 Patient Sequence Number: 1
-
-