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The following information was provided by the Pennsylvania Department Bureau of Radiation Protection (the Department) via email: On July 3, 2024, the licensee informed the Department of a medical event involving a treatment with SirSpheres (Y-90 resin microspheres). A patient was about to undergo a treatment with SirSpheres when the physician noticed a globule on the vial septum. They cleared the globule and began the treatment. At the beginning of treatment, the tube became occluded immediately, resulting in the patient receiving only 0.2% of the prescribed dose. The procedure was stopped. The physician and patient have been informed. No harm to the patient is expected from this event. PA Event Report ID: PA240014

• * * UPDATE ON 7/15/2024 AT 1050 EDT FROM JOHN CHIPPO TO SAMUEL COLVARD * * *

The following is information provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (DEP) via email: On July 11, 2024, the Authorized User (AU) for the event was interviewed and provided the following additional information: The treatment used Y-90 SirSpheres administered through the `SIROS' apparatus. The treatment location was the right lobe of the liver. When the vial was placed into the apparatus the `C' and `D' lines were not in the right location and no spheres were at the bottom of the dose vial where they usually are. The AU saw the spheres clumped at the top of the dose vial, so they agitated the vial to try to suspend the spheres. The vial was then connected to the `SIROS' unit. The AU started the procedure by trying to push a 20 mL syringe of saline solution through the `D-Line' which connects to the dose vial. After many attempts the AU could not get any solution through the `D-line' which he thought may be occluded. The AU then checked the patient's catheter line with contrast and tried to slightly move the catheter. The AU then connected a 3 mL syringe to the `D-line' to create more pressure to try to push the solution to the dose vial, but the line remained occluded. The treatment was then terminated. The patient was retreated on July 10th, 2024, successfully. The Department will perform a reactive inspection. Notified R1DO (Schroeder), NMSS Events Notification (email). A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

• * * RETRACTION ON 7/18/2024 AT 1407 EDT FROM PA DEP BEREAU OF RADIATION PROTECTION TO JORDAN WINGATE* * *

The following is information provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (DEP) via email: After the licensee's physicists performed all calculations and consultation with the NRC, it was determined that no dose was delivered and since no material was administered the dose threshold would not be met and there would not be a radiation protection concern to the patient. Therefore, this is not considered a medical event and PA wishes to formally retract the submission. Notified R1DO (Schroeder), NMSS Events Notification (email).