MAUDE Adverse Event Report: SIRTEX, WILMINGTON MA SIR-SPHERES MICROSPHERES; Y90 RESIN MICROSPHERES

Model Number SIR-Y001

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

An activity of 8.1mci was prescribed for this procedure.The total drawn dose was 8.4mci.The treating ir performed 3 aliquots that were delivered to the patient without incident.The flow to the tumor was hypervascular in nature.The final aliquot was delivered during airphase and the 3-way stopcock was cleared.The remaining vial, tubing set, and microcatheter were prepped and contained in the mayo jar per protocol.The post reading showed that 6.2mci was delivered which was 77% of the prescribed activity.There was no activity detected outside of containment.There was no harm to the patient.The 6.2mci still represents a therapeutic activity to the target tumor.

• Brand Name: SIR-SPHERES MICROSPHERES
• Type of Device: Y90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• MDR Report Key: 11788516
• MDR Text Key: 252360455
• Report Number: 3005579300-2021-00003
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: P990065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIR-Y001
• Device Lot Number: PD025V08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2021
• Date Manufacturer Received: 04/19/2021
• Type of Device Usage: N
• Patient Sequence Number: 1