|AGREEMENT STATE REPORT - HIGH DOSE RATE TANDEM APPLICATOR BROKEN DURING TREATMENT
The following was received via E-mail from the State of Texas:
"On June 23, 2020, the licensee reported that at approximately 0900 CDT, a Medical Event occurred at its facility. The event involved a patient receiving an High Dose Rate (HDR) cervix treatment with a Nucletron Model microSelectron using a tandem and ring. The device contained a 5.191Curie Iridium-192 source. After the treatment was completed and the device was removed, it was discovered the tandem had broken into two pieces. The licensee stated it is unknown where the source was positioned during the treatment. The licensee reported no warnings or errors from the machine were recorded from either the check source or the treatment cable. The licensee stated the source was in the patient for a total of 564.7 seconds. The source was in the tandem a total of 355.2 seconds of that total time. The licensee stated the physician has been notified, but was not sure if the patient had been notified. The licensee stated they were still investigating what occurred and will provide more specific information as it is discovered. Additional information will be provided as it is received in accordance with SA300."
Texas Incident No.: 9774
* * * UPDATE FROM ART TUCKER TO DONALD NORWOOD AT 0902 EDT ON 6/30/2020 * * *
"The break in the tandem occurred about four inches from the end of the tandem. A picture provided by the licensee shows the break at the beginning of the bend in the tandem on the insertion end at the start of the ring. The licensee stated using the location of the guide wire, which they could track, it now appears that the source tracked next to the tandem and that the exposure occurred only to the intended tissue. The manufacture is investigating the event with the licensee. Additional information will be provided as it is received in accordance with SA300."
Notified R4DO (Silva) and NMSS Events Notification E-mail group.