At approximately 1:00
PM September 17, 2003 the Agency was informed of a medical event. The reporting individual indicated that in the course of treating a breast cancer, a saline filled balloon was used to aid in positioning the
HDR source,
Iridium 192, approximately 9.589 curies. Starting September 15, 2003, a series of 10 fractional treatments was prescribed. Between each, an ultra sound image was made to assure the continued proper placement of the source. The ultra sound technician indicated all was ok for all treatments. After the series was completed, the balloon was deflated for removal and the physician then noted that the balloon had ruptured. A review of the retained ultra sound images indicated [that] starting with treatment 7 the balloon was deflated. The doses were recalculated and the tissue dose was 40 [percent] higher than prescribed. The adjacent skin dose was calculated to be 266 cGy [centigray] rather than the 175 cGy [centigray] as originally calculated. The licensee has proposed corrective measures to prevent a recurrence of this event. The balloon manufacturer has been informed of this event.
The patient has been informed of the event. The medical review indicates some additional fat necrosis and possible inflammation may occur. It will be reviewed as a part of the patient follow up.