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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIR-SPHERES MICROSPHERES; Y90 RESIN MICROSPHERES
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SIRTEX MEDICAL PTY LIMITED SIR-SPHERES MICROSPHERES; Y90 RESIN MICROSPHERES Back to Search Results
Model Number SIR-Y001
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2022
Event Type  malfunction  
Manufacturer Narrative
The batch review and manufacturing records did not reveal any manufacturing issues with the sir-spheres.The device was not returned for investigation.This incident was initially assessed as a non-reportable event.A second review that was recently conducted, concluded that this event should have been reported.
 
Event Description
Procedure included a segmental delivery with multiple aliquots.Everything prior and during the procedure looked normal.When the post procedure 4 point survey was done the healthcare professional realized that only 40% of the prescribed dose was delivered to the patient.No further information have been provided.
 
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Brand Name
SIR-SPHERES MICROSPHERES
Type of Device
Y90 RESIN MICROSPHERES
Manufacturer (Section D)
SIRTEX MEDICAL PTY LIMITED
207 pacific highway
shop 6
st. leonards 2065
AS  2065
Manufacturer Contact
vana poovala
300 unicorn park drive
floor 2
woburn, MA 01801
8884747839
MDR Report Key18788562
MDR Text Key336337145
Report Number9710358-2024-00001
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 Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIR-Y001
Device Lot Number0K029V14
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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