|AGREEMENT STATE REPORT - DOSE NOT DELIVERED TO THE CORRECT LOCATION DURING BRACHYTHERAPY TREATMENT
The following was received from the state of Texas via email and by telephone:
"On April 10, 2020, the licensee reported to the Agency [Texas Department of State Health Services] that it had an event on April 9, 2020, involving a Novoste device in which the source train had not advanced to the designated treatment site during two attempts to deliver intravascular brachytherapy to a patient. It was unclear if the source train had actually entered the patient and the Agency requested confirmation and more information. On April 14, 2020, the licensee reported back to the Agency confirming that the source train had stopped moving after it had entered the patient. During the first attempt, the source train of 16 Strontium-90 sources in the Novoste device failed to go to the expected treatment position and instead got stuck in the beta-rail catheter proximally to the treatment area for 6 minutes 54 seconds. The device was checked and a second attempt was made during which the source got stuck in the beta-rail catheter proximally to the desired treatment area for 3 minutes 41 seconds. The source train was stuck at different positions in the catheter for the two attempts and each time the physicians worked with the catheter to try and get the source train to move to the treatment site. Doses calculated for each of the locations: first location = 26.2 Gy at 2 mm; second location = 14.2 Gy at 2 mm. The licensee was able to fully retract the source into the device each time. The vendor is expected onsite next week to check the device and investigate the cause. The licensee has suspended this particular treatment program indefinitely pending identification of cause.
Novoste device SN: 89670
Source train SN: ZA925
Active source train length: 40 mm
Number of Sr-90 sources: 16
Total activity: 2 GBq calibrated on 8/16/2002
Vessel description: RCA
Vessel diameter: 4 mm
Lesion length: 30 mm
Radiation dose: 23 Gy
Dwell time: 5 minutes and 57 seconds
"Dose to staff was negligible since the source train was inside the patient. Effects to the patient, if any, as a result of this event were not reported with this initial information. An investigation into this event is ongoing. More information will be provided as it is obtained in accordance with SA-300."
Texas Incident Number: I-9760
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.