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

Model Number SIR-Y001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Gastritis (1874); Pain (1994); Ulceration (2116)

Event Date 01/09/2018

Event Type  Injury  

Event Description

Patient with complicated anatomy received sirt treatment.Despite difficulty anatomy, dose was able to be delivered and everything was thought to be alright.Patient had ongoing pain several weeks out and was referred to the gi group who performed an endoscopy.Diagnosis was ulcerative gastritis of the esophagus.Patient was treated by the gi team.

• Brand Name: SIR-SPHERES MICROPSHERES
• 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 WILMINGTON LLC; unit 2-4, 16 upton drive; wilmington MA 01887
• Manufacturer Contact: grant spindler ; level 22, 101 miller st; north sydney, nsw 2060 ; AS 2060
• MDR Report Key: 7875700
• MDR Text Key: 120241393
• Report Number: 9710358-2018-00001
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• 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: 02/21/2018
• 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 Number: 1
• Patient Outcome(s): Other