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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

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BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Injury (2348); Radiation Exposure, Unintended (3164)
Event Date 01/01/2015
Event Type  Death  
Event Description
Developed radiation-induced liver damage/died within 6 months [radiation injury]. Case description: initial information received on 12-jan-2017 merged with additional information received on the same day: this spontaneous medical device report was received from a consumer via a licensee partner, concerning an (b)(6) year-old female patient. The patient's medical history included liver cancer resulting from years of (b)(6) with suspected recurrence of liver cancer. The patient's concomitant medications were not reported. On (b)(6) 2015, the patient received thermosphere (lot number, expiration date and dose not reported) for suspected recurrence of liver cancer. On an unspecified date in 2015, after the radio-embolization procedure with thermosphere, the patient developed radiation-induced liver damage and died within six months on (b)(6) 2015. The cause of death was radiation-induced liver damage. The autopsy results were not reported. The reporter did not assess the seriousness of the event, yet considered the radiation-induced liver damage as related to thermosphere. The company considered the event radiation-induced liver damage as serious (fatal, medically significant). Follow-up information will be requested. Case comment: the event radiation injury is considered listed according to thermosphere current reference safety information. However death due to radiation injury is unexpected. In agreement with the assessment made by the reporter, the company considered the event radiation injury related to the use of thermosphere. This single case report does not modify the risk benefit balance of thermosphere. The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
 
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Brand NameTHERASPHERE
Type of DeviceYTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
Manufacturer (Section D)
BIOCOMPATIBLES UK LTD
chapman house farnham bus park
weydon lane
farnham, surrey GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK
chapman house
weydon lane
farnham, surrey GU9 8 QL
UK GU9 8QL
Manufacturer Contact
sandra bausback-aballo
300 four falls corporate cente
300 conshohocken state road
west conshohocken,, pa 
3311537
MDR Report Key6636016
MDR Text Key181087084
Report Number3002124543-2017-00001
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2017 Patient Sequence Number: 1
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