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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRTEX MEDICAL LIMITED SIR-SPHERES MICROSPHERES; YTTRIUM 90 RESIN MICROSPHERES
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SIRTEX MEDICAL LIMITED SIR-SPHERES MICROSPHERES; YTTRIUM 90 RESIN MICROSPHERES Back to Search Results
Model Number SIR-Y001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Gastritis (1874); Hepatitis (1897); Ulcer (2274)
Event Date 05/31/2018
Event Type  Death  
Event Description
Patient developed radiation duodenitis and gastritis with large gastric ulcer, and radiation hepatitis which was ultimately fatal.Patient died (b)(6) 2018.
 
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Brand Name
SIR-SPHERES MICROSPHERES
Type of Device
YTTRIUM 90 RESIN MICROSPHERES
Manufacturer (Section D)
SIRTEX MEDICAL LIMITED
level 33
101 miller st
north sydney, nsw 2060
AS  2060
Manufacturer (Section G)
SIRTEX SINGAPORE MANUFACTURING
01-01 the kendall
50 science park rd
singapore, singapore 11740 6
SN   117406
Manufacturer Contact
grant spindler
level 33
101 miller st
north sydney, nsw 2060
AS   2060
MDR Report Key7916960
MDR Text Key121992093
Report Number9710358-2018-00003
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P990065
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberSIR-Y001
Device Catalogue NumberSIR-Y001
Device Lot NumberMC211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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