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

Model Number	SIR-Y001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The described issue stated in the incident report could not be reproduced during the investigation.Water flowed freely through the lines of the device in all configurations, and no pressure was felt.The device history records (dhr) review showed no abnormalities during the manufacturing process and that the product met the production acceptance criteria per established manufacturing production instructions.The reported incident was likely attributed to operator technique, or a connection during the operation that could not be replicated during the investigation of the device.The root cause of the incident cannot be confirmed.
Event or Problem 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.(b)(6) was no longer able to inject.

• Brand Name: SIR-SPHERES MICROSPHERES
• Common Device Name: 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
• Report Number: 3005579300-2024-00001
• Device Sequence Number: 16905926
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIR-Y001
• Device Lot Number: SB031V05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown