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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 Patient-Device Incompatibility (2682)
Patient Problems Chest Pain (1776); Death (1802)
Event Date 07/25/2018
Event Type  Death  
Event Description
Patient died within 48 hours of the procedure.In the middle of the procedure the patient was experiencing chest pain and they brought in an ekg and proceeded with the administration of sir-spheres.Immediately following the procedure a rapid response team was deployed to ir.I could clearly tell under x-ray that the patient had prior open heart surgery.
 
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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 street
north sydney, nsw 2060
AS  2060
Manufacturer (Section G)
SIRTEX WILMINGTON LLC
unit 2-4
16 upon drive
wilmington MA 01887
Manufacturer Contact
rachel tserng
level 33, 101 miller street
north sydney, nsw 2060
AS   2060
MDR Report Key8101617
MDR Text Key128300221
Report Number9710358-2018-00004
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P990065
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2018
Was Device Evaluated by Manufacturer? No
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;
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