On August 31, 2006 a female patient received mammosite treatment for a breast lesion using a
HDR with an
Ir-192 source. The treatment consisted of placing a catheter into the treatment site, inflating a balloon with between 35-75 ml saline and positioning the
Ir-192 source inside the catheter into the center volume of the saline balloon. This allows for a homogenous dose to the treatment site. While in the
OR (Operating Room), the catheter was inserted and saline introduced through one of the two catheter connections to inflate the balloon. The patient was taken to the
HDR location where the technologist inadvertently connected the
HDR to the saline vice the
HDR connector. This resulted in draining the saline balloon into the
HDR unit. The technologist recognized that the
HDR was improperly connected, broke the connection and reconnected to the proper port. When the prescribed 416 second treatment was commenced, the
HDR automatically shutdown after 223 seconds retracting the
Ir-192 source to the safe position. An evaluation by the licensee concluded that the incident was not reportable since it did not meet the criteria for an
underdose.
During an inspection conducted 7/26/07 (Inspection Report No. 2007-001), the NRC Inspector noted that since the saline balloon had been inadvertently drained tissue in a .5 cubic centimeter volume adjacent to the source received a significantly higher dose (approximately 20 Gray) than prescribed. In a follow-up call from NRC Region I on 10/03/07, the licensee was requested to notify the NRC Operations Center of this finding.
The licensee informed the prescribing physician and the patient was also notified. No adverse effects to the patient have been noted.
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.