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The following information was received via email from the Pennsylvania Department of Environmental Protection (the Department): On August 21, 2023 the licensee informed the Department of a medical event where the equipment failed to function as designed. This is reportable under 10 CFR 30.50(b)(2). A patient was scheduled for an intravascular brachytherapy (IVBT) patient treatment using a Beta-Cath Strontium 90 device (s/n 91273) and upon source retraction the source failed to return to the transfer device due to a kink in the catheter. An emergency 'bailout' procedure was performed, with the cardiologist removing the delivery catheter and guidewire from the patient. The delivery catheter was left attached to the transfer device and placed it into the temporary plexiglas 'bailout' box. The patient was surveyed to confirm the source had been removed. The 'bailout' box was visually inspected and surveyed to confirm the source was in the catheter in the box. This box was then transferred to the radiation oncology secure storage area. The device will be returned to the manufacturer for inspection. No overexposures were reported. The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received. PA Event Report ID Number: PA230022 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.

• * * UPDATE FROM JOHN CHIPPO TO DONALD NORWOOD AT 1357 EDT ON 8/23/2023 * * *

The following information was received via email from the Department. The event type has been changed from a medical event to a Part 30 equipment event. The Department has learned that the authorized user said that treatment was complete and the source did not enter the device within 3 seconds so they started emergency removal of catheter from the patient and placed it in the 'bailout' box; total time from end of treatment to the catheter/device in the emergency box was approximately 10 seconds. The kink in the catheter was noted after it and the source were approximately 15 cm from where it entered the patient thus no overexposure or unintended dose. Device make, model, serial number: Best Vascular, Inc, A1000 Series Models, Transfer Device s/n 91273. Radionuclide: Sr-90; Jacketed Radiation Source Train s/n ZB948 (60 mm source train) (24 sources). Source strength(s): 3.13 Gbq (84.6 mCi) total; (3.52 mCi/source * 24 sources); Assay date 12/3/2003; Activity as of August 21, 2023 = 1.92 Gbq (51.9 mCi) total. Dose patient received:18.4 Gray @ 2 mm; (vessel 3.0 mm). Dose patient prescribed:18.4 Gray @ 2mm (vessel 3.0 mm). Notified R1DO (Gray) and NMSS Events Notification email group.

The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: On April 19, 2024, the licensee informed the Department of a medical event. It is reportable per 10 CFR 35.3045. On April 19, 2024, the licensee discovered a medical event from December 28, 2022. A patient received a diagnostic scan that was performed using 1 mCi of I-131. This scan was performed without a written directive being prepared. Immediately upon discovery, the authorized users and technologists received training to remind them that they are required to verify the prescribed dosage to be administered against a prepared written directive. The licensees system was modified to remind the employees to verify the prescribed dosage in the written directive against the dosage about to be administered. No harm is expected to the patient. At this time, no other information is available. The Department will update this event as soon as more information is provided.

• * * RETRACTION ON 4/23/24 AT 0740 EDT FROM JOHN CHIPPO TO BILL GOTT * * *

The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: The Department wishes to retract this event as it does not meet the qualifications for reporting. Notified R1DO (Werkheiser) and NMSS Events Notification via email. PA Event Number: PA240008 A Medical Event may indicate potential problems in a medical facilitys use of radioactive materials. It does not necessarily result in harm to the patient.

The following was received from the Pennsylvania Department of Environmental Protection (the Department) via email: On May 19, 2022, the licensee informed the Department of an incident involving Cobalt 60 in a Leksell (R) Gamma Knife Perfexion. It is reportable as per 10 CFR 35.3045(a)(1). On May 18, 2022, a patient underwent treatment of four lesions in the brain. Upon review of the treatment, the physicist noticed that all four lesions were missed by approximately 0.5 centimeters and healthy brain tissue was treated. The patient and referring physician have been informed. The Department is currently in contact with the licensee and will update this event as soon as more information is provided. The Department will perform a reactive inspection. More information will be provided as received. Event Report ID No: PA220018 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.

• * * UPDATE ON 05/25/2022 AT 0949 EDT FROM JOHN CHIPPO TO OSSY FONT * * *

The following updated was received from the Department via email: The patient had MRIs and CT Scans. Those images were fused by the neurosurgeon and radiation oncologist. Upon completion of the treatment, they discovered that although the targets were moved with the second image fusion, the shots and contours were not. This resulted in the treatment being 0.5 cm off for all 4 targets. Prescribed dose was 20 to 21 Gy, delivered dose to target tissue was 8 to 15 Gy, maximum dose to healthy tissue is estimated to range from 21.82 to 27.09 Gy. More information is expected once the licensee completes their investigation. Notified R1DO (Eve) and NMSS Events Notification via email.

The following information was received via email: The Department (Pennsylvania Bureau of Radiation Protection) received notification from a licensee on May 5, 2020, of a medical event involving a Varian GammMedplus iX high dose rate remote afterloader (HDR) containing 8.6 Ci of iridium 192. The patient was set to receive 10 fractions (channels) of breast cancer treatment. An error was noted when treatment from the third channel was attempted. The source was retracted back into the safe position upon the error indication. Staff reset the unit and rebooted. The unit functioned normally for the fourth channel. During the fifth channel the machine experienced another fault, but the source did not automatically retract. Staff then attempted two emergency stop procedures; however, both failed. Staff were finally able to manually retract the source after approximately two to four minutes; however, it hasn't been determined if the source was completely retracted into the shielded safe on the HDR due to catheter interference. The patient was quickly disconnected from the catheter, everyone was immediately removed, and the room was secured from entry. No dose is expected outside the HDR room as it is housed within an accelerator vault. The manufacturer has been contacted. The licensee has also requested the log files from the manufacturer for dose reconstruction of those involved. The department is currently in contact with the licensee and will update this event as soon as more information is provided. PA Event Report ID No: PA200011

• * * UPDATE ON 5/7/20 AT 1208 EDT FROM JOHN CHIPPO TO ANDREW WAUGH * * *

The following information was received via email: Manufacturer service technicians removed the wire/source from the afterloader on 5/6/2020. Preliminarily, it appears the source became stuck approximately 4 to 5 inches from the shielded park position (inside the afterloader, but outside the shielded safe). Dosimetry badges have been sent for emergency read, results are expected today, and those results are expected to be minimal. The patient and all personnel involved were surveyed after the incident and readings were at background levels. Notified R1DO (Dentel) and NMSS Event Notifications (email).

• * * UPDATE ON 5/12/20 AT 1158 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *

The following information was received via email: The preliminary dosimetry report indicates three staff members involved in the event. The technologist received 4 mrem whole body dose, the authorized user received 3 mrem whole body dose and the AMP received 3 mrem whole body dose and a 15 mrem dose on their finger dosimeter. No other dose information was received at this time. Notified R1DO (Lally) and NMSS Event Notifications (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.

The following was received from the State of Pennsylvania via E-mail: The (PA DEP Bureau of Radiation Protection) Department received notification from a licensee on April 3, 2020 of a medical event involving Y-90 TheraSphere microspheres. The licensee believes a patient undergoing a multiple lobe injection of the liver received only 62.7 percent of the prescribed dose in one of the lobes. The second lobe is believed to have received the correct dose. The DEP is currently in contact with the licensee and will update this event as soon as more information is provided. The Department will perform a reactive inspection as soon as possible. Pennsylvania Event Report ID No.: PA200007

• * * UPDATE ON 04/07/2020 AT 1353 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *

The following was received from the State of Pennsylvania via E-mail: The patient was prescribed TheraSphere Y-90 Microspheres at 2.47 GBq total with 2.25 Gbq prescribed to the liver because of 9.1 percent lung shunt. The licensee reports total dose 1.536 GBq, and 1.4 GBq to liver. Ultimately only 62.7 percent (75.3 Gy) of the planned dose was able to be administered to segment 6 of the liver. While attempting to administer the Y-90 dose to treat a lesion in Segment 6 of the liver there was significant resistance to flow. The AU evaluated the microcatheter system to ensure that there were no kinks along the catheter course external to the patient or visualized internally under fluoroscopy. The licensee believes the issue came from blockage at or before the 'E' site on the labeled tubing of the administration set, given that when it was disconnected from the microcatheter at that location, they were able to successfully flush the catheter. The patient then had a subsequent segment 7 segmentectomy using tubing from a box set from a different lot number without incident. No adverse effects to the patient are anticipated and the patient and referring physician were notified the day of the event. Notified R1DO (Lilliendahl) and NMSS Events Notification 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.

EN Revision Imported Date : 1/10/2020 AGREEMENT STATE REPORT - HIGH DOSE RATE APPLICATOR DISLODGED The following was received from the PA Department Bureau of Radiation Protection (DEP) via fax: On December 16, 2019, the medical physicist for the licensee verbally reported that during an HDR (high dose rate) treatment using a Varian Model VariSource IX with a Tandem & Ovoid applicator, the applicator was found dislodged at the end of the treatment period. This was fraction 4 of 5 planned fractions. It is unknown at this time how long the applicator was not in the planned position or what caused it to move. The prescribed dose was 600 cGy from a 5.126 Ci Iridium-192 source. No further information is available at this time. The DEP will update this event as soon as more information is provided. Event Report ID No: PA190029 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.

• * * UPDATE ON 1/9/20 AT 1:17 PM FROM JOHN CHIPPO TO KARL DIEDERICH * * *

The following information was received from the Agreement State via fax: The patient was seen on 12/27/2019, 12/30/2019, and 1/6/2020 for follow-up appointments. Observed skin effects were described as 'moist desquamation' due to the applicator being dislodged from the vaginal canal and positioned against the skin. The patient is being treated with Silvadene topical cream and will be followed up with regular skin checks. Based on the evidence observed, the licensee assumes that the applicator was against the skin long enough to deliver a skin dose in the range of 10-30 Gy. This dose makes the event a potential Abnormal Occurrence. The Department has performed a reactive inspection and continues to investigate the event. Notified R1DO (Schroeder) and NMSS group (via e-mail).

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.