MAUDE Adverse Event Report: SIRTEX MEDICAL LIMITED SIR-SPHERES MICROSPHERES; YTTRIUM 90 RESIN MICROSPHERES

Model Number SIR-Y001

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Patient administered 592 mbq (16mci) on (b)(6) 2018.Patient passed away soon after treatment.

• 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; 16 upon drive, unit 2-4; wilmington MA 01887
• Manufacturer Contact: rachel tserng ; level 33; 101 miller street; north sydney, nsw 2060 ; AS 2060
• MDR Report Key: 8276507
• MDR Text Key: 134060318
• Report Number: 9710358-2019-00001
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P99065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SIR-Y001
• Device Catalogue Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death