EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT
The following was received from the Commonwealth of Pennsylvania via email:
The Department [Pennsylvania Department of Environmental Protection] received notification from a licensee on November 6, 2019 that on October 8, 2019 they performed a prostate seed implant on a patient including seventy (70) stranded I-125 seeds that were implanted into the prostate treatment volume. They were Best Medical, Model 2301, Lot 48917, at 0.350 mCi per seed and 24.5 mCi total activity. The patient had an appointment on November 5, 2019 for a 30-day post-plan analysis. The CT from November 5, 2019 noted 2 seeds that were outside the prostate volume in the peril-prostatic fat. The post-plan analysis showed that 68 of 70 seeds are within the treatment volume and 94.4 percent of the treatment volume is covered by the prescription dose, which are within appropriate specifications for a prostate seed implant. The two seeds in question are considered discontinuous from the treatment volume. The licensee believes when the needle was retracted, the strand of seeds drug back with the needle and was deposited inferior from their intended location. An analysis was performed by the licensee and no adverse effects to the patient are expected. Both the patient and referring physician were notified. The Department will update this event as soon as more information is provided.
Pennsylvania Event Report ID No: PA190026
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 11/19/19 AT 1148 EST FROM JOHN CHIPPO TO THOMAS KENDZIA * * *
The following was received from the Commonwealth of Pennsylvania via fax:
As a result of a reactive inspection by the Department and an extensive review by the licensee, the licensee has determined the tissue containing the two seeds is within the contiguous peril-prostatic fat, which is actually physically adjacent to or touching the prostate, therefore this is not a reportable event. Further, changes noted in the radiograph taken on the day of the implant and the post-plan CT can be accounted for by the difference in patient positioning; from the lithotomy position for the implant image to the supine position for the post-plan image.
Notified the R1DO (Cahill) and
NMSS Event Notification via email.