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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5661911 July 2023 21:00:0010 CFR 35.3045(a)(2)Medical Event - Dose MisadministrationThe following information was provided by the licensee via phone: On July 11, 2023, at 1700 EDT, an intravascular brachytherapy treatment was delivered to the wrong treatment site. The original dose of 23 Gy was intended for a different part of the vasculature system. The brachytherapy device made by Best Vascular is a Beta-Catch (model # 5ICW-2) containing 3.62 GBq of Sr/Y-90. Physicians expect that there will be no permanent damage to any of the patient's organs. 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.
ENS 565128 May 2023 04:00:0010 CFR 35.3045(a)(2)Potential Medical Event

The following information was provided by the licensee via phone and email: In accordance with 10 CFR 35.3045, (Henry Ford Hospital is) reporting a potential medical event. On May 8, 2023, a patient was treated with Y-90 TheraSpheres. The total activity prescribed in the written directive was 11.5 mCi to the left lobe of the liver and 11.37 mCi was delivered (99.2 percent). The therapeutic dose was prescribed to be delivered to segment 4 of the left lobe of the liver. During treatment, the position of the catheter was verified and was determined by the physician to be in the correct position. However, post-treatment bremsstrahlung imaging reviewed today on 5/9/2023 indicated some activity was shunted unexpectedly to segments 2 and 3 of the left lobe of the liver. Based on preliminary calculations, this discrepancy could be categorized as a medical event.

  • * * RETRACTION FROM ALAN JACKSON TO BILL GOTT AT 0907 EDT ON 05/10/2023 * * *

The following information was provided by the licensee via phone: Since the exposure was due to shunting, the licensee determined that this event is not reportable in accordance with the licensing guide. This event is being retracted. Notified R3DO (Feliz-Adorno), NMSS (Rivera-Capella), and NMSS Events Notification. 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.