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

Model Number SIR-Y001

Device Problem Insufficient Information (3190)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

During the administration of the second dose of a split dose case of sir-spheres treatment, dr.(b)(6) was no longer able to inject through either the b or d lines.Dr.(b)(6), who was proctoring dr.(b)(6) , was also present and assisted in trouble shooting to attempt to clear the line.The line was pulled and case was completed.The entire system was sent to be decayed.Post survey showed approximately 45% of the dose was delivered to patient prior to clogging (prescribed dose.3gbq, administered was.14 gbq).Non-sirtex equipment used was a sim 2 catheter into the celiac trunk and 2.4fr.Progreat into the distal portion of segment 7.Nuc med is holding the system until it's decayed to background and will ship back for quality to check the system to see if the issue was the siros tubing or a clogged/kinked microcatheter.Also of note, inside of siros box was hot treatment.The d port connection going into the d-vial was cracked.Suspect due to pressure build up within the system when dr.Hazelton was no longer able to inject.

• Brand Name: SIR-SPHERES MICROSPHERES
• Type of Device: Y90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• Manufacturer Contact: 300 unicorn park; woburn, MA 01801 ; 8884747839
• MDR Report Key: 18826214
• MDR Text Key: 337776726
• Report Number: 3005579300-2024-00001
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIR-Y001
• Device Lot Number: SB031V05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• 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 Number: 1