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

Model Number	SIR-Y002
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While drawing dose in hot lab, a small particle was observed inside the vial.After investigating, it was determined that a piece of septum detached and was displaced into the vial.No residue/particles were observed in the d-vial doses and draw continued.Particle observed inside y-90 vial during draw, which was determined to be septum.Needle must have detached a portion of septum during draw.
Additional Manufacturer Narrative
Sirtex medical team has stated the risk of potential patient harm is not clinically significant.The catheter diameter and in-line filters would prevent such a septum fragment from reaching the patient.A comprehensive device history record review was performed for this product batch and did not result in any abnormal findings related to the manufacturing process.

• 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: melissa sanchez ; 300 unicorn park; woburn, MA 01801
• MDR Report Key: 22805344
• Report Number: 3005579300-2025-00007
• Device Sequence Number: 21072812
• Product Code: NAW
• UDI-Device Identifier: 00850014612146
• UDI-Public: (01)00850014612146(17)250712(10)TG018
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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 Expiration Date: 07/12/2025
• Device Model Number: SIR-Y002
• Device Lot Number: TG018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown