EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT
The following was received from the State of Utah via email:
The licensee informed the State of Utah they are evaluating a potential medical event. A patient was implanted with 54 Pd-103 seeds in the prostate under ultrasound guidance. Per standard practice, the patient returned for a CT scan to verify the placement of the seeds. The CT scan revealed that 32 of the seeds had been implanted outside of the prostate. In addition, only 51 seeds were located, likely the result of 3 seeds being passed via stool. They believe that several additional seeds are in the rectum and will be passed following an enema.
Utah Event Report ID No.: UT180003
- * * UPDATE ON 8/17/2018 AT 1106 EDT FROM TIM BUTLER TO ANDREW WAUGH * * *
The following update was received from the State of Utah via email:
The licensee reported a medical event involving a patient treated for prostate cancer. The treatment included implanting 54 Pd-103 brachytherapy [seeds] (Theragenics, Theraseed) containing a total activity of 4 GBq (108.167 mCi), in the patient's prostate for a prescribed therapeutic radiation dose of 12,500 cGy (rad). The prostate gland only received approximately 1,000 cGy (rad). The seeds were implanted on June 14, 2018 under ultrasonic guidance. On June 15, 2018, the patient returned to the facility for a post implant CT scan. The scan showed that the implanted seeds, although in an appropriate pattern, were placed outside the intended target. The Licensee's Radiation Oncology group determined that an additional quality assurance review was warranted. The State performed a reactive inspection during the week of June 15, 2018. The cause was determined to be human error. An unintended dose to the rectum of approximately 18,677 cGy (rad) was received, where no dose was anticipated. Corrective actions included changes to the prostate brachytherapy protocol to incorporate an additional step to ensure the medical physicist and authorized user clearly identifies the prostate gland and the surrounding anatomy. The treatment will be cancelled if the prostate gland and surrounding anatomy cannot be visualized adequately.
Notified R4DO (Deese), INES Coordinator (Milligan), and NMSS Event Notifications via 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.