The following information was received from the state of
North Carolina via email:
A licensee reported a medical event involving a patient treated for prostate cancer. The treatment included implanting 54 iodine-125 brachytherapy seeds, containing a total activity of 1.012986 GBq (27.378 mCi), in the patient's prostate for a prescribed therapeutic radiation dose of 14500 cGy (rad). The seeds were implanted on 7/26/21. On 8/17/21, the patient's follow up implant CT scan revealed that all 54 seeds were implanted in the penile bulb, outside of the intended target. An inspector was dispatched on 8/18/21. The patient and physician were notified. Through subsequent interviews with the Medical Physicist involved, the Radiation Safety Officer, and the Chief Physicist, malfunction of the ultrasound unit was ruled out. A discussion evolved during review of the ultrasound images from the procedure where a foley catheter inserted in the patient appeared partially visible marking the location of the bladder. The physicist's retrospective review indicates that if the foley catheter is not clearly visible then it could result in seed implantation in a patient's anatomy other than the prostate.
An unintended dose to the penile bulb of approximately 14500 cGy (rad) was received, where no dose was anticipated.
Currently, the cause appears to be human error and our investigation is ongoing. Pending corrective actions include changes to the prostate brachytherapy protocol to incorporate an additional step to ensure personnel clearly identify the prostate gland and the surrounding anatomy. Previous cases involving this type of procedure do not indicate that this error has been occurring, unaccounted for, prior to this event, due to the follow-up CT scans performed post-op per the licensee's internal procedures.
NMED Report No.: NC210014
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.