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The following report was received from theThe following report was received from the State of Wisconsin via facsimile:</br>On 7/14/2008, a patient was simulated and treatment planning performed for High Dose Rate (Ir-192) partial breast irradiation to the right breast using a Contura (SenoRx) balloon. The authorized user prescribed a dose of 3.65 Gy per fraction x 9 fractions for a total dose of 32.85 Gy to the Planning Target Volume. After the planning was done, the length of each of the five catheters was measured by the Nucletron Source Position Simulator. The readings were found to be 1154 each. The treatment file in the High Dose Rate treatment console was modified from its default value of 1500 to 1154 and patient was treated. The patient was treated in the High Dose Rate machine located in Room 'A'.</br>On 7/15/08, the patient was scheduled to be treated in the High Dose Rate machine located in Room 'B'. Since the sources are different in activity, total time check was performed, at which time, the medical physicists also compared the measured lengths with a second patient under treatment with the Contura balloon in Room 'B'. At this point they noted the difference in the measured lengths between the two cases. The medical physicist checked the Source Position Simulator and noticed that there was an obstruction at the 1154 reading. The review of the actual delivered dose during the first fraction revealed that the source did not enter the patient's body and thus the negative impact was mitigated. A small region of the skin surface received some radiation dose, but the clinical impact is insignificant. The incident was immediately reported to the primary Radiation Oncologist and the Authorized User. The licensee states that no long-term, permanent side effects are anticipated as a result of the medical event.</br>Due to the licensee's investigation of the Source Position Simulator revealing that a welded junction in the cable of this measuring device was kinked, it was immediately replaced with a new one. The licensee has also developed a new Quality Assurance form which will be exclusively used for Contura balloons and which incorporates the expected length for the five catheters. Department of Health Services (DHS) staff have been dispatched to investigate this incident.</br>Wisconsin Report Number: WI080017</br>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.necessarily result in harm to the patient.  
05:00:00, 14 July 2008  +
44,353  +
12:05:00, 17 July 2008  +
05:00:00, 14 July 2008  +
The following report was received from theThe following report was received from the State of Wisconsin via facsimile:</br>On 7/14/2008, a patient was simulated and treatment planning performed for High Dose Rate (Ir-192) partial breast irradiation to the right breast using a Contura (SenoRx) balloon. The authorized user prescribed a dose of 3.65 Gy per fraction x 9 fractions for a total dose of 32.85 Gy to the Planning Target Volume. After the planning was done, the length of each of the five catheters was measured by the Nucletron Source Position Simulator. The readings were found to be 1154 each. The treatment file in the High Dose Rate treatment console was modified from its default value of 1500 to 1154 and patient was treated. The patient was treated in the High Dose Rate machine located in Room 'A'.</br>On 7/15/08, the patient was scheduled to be treated in the High Dose Rate machine located in Room 'B'. Since the sources are different in activity, total time check was performed, at which time, the medical physicists also compared the measured lengths with a second patient under treatment with the Contura balloon in Room 'B'. At this point they noted the difference in the measured lengths between the two cases. The medical physicist checked the Source Position Simulator and noticed that there was an obstruction at the 1154 reading. The review of the actual delivered dose during the first fraction revealed that the source did not enter the patient's body and thus the negative impact was mitigated. A small region of the skin surface received some radiation dose, but the clinical impact is insignificant. The incident was immediately reported to the primary Radiation Oncologist and the Authorized User. The licensee states that no long-term, permanent side effects are anticipated as a result of the medical event.</br>Due to the licensee's investigation of the Source Position Simulator revealing that a welded junction in the cable of this measuring device was kinked, it was immediately replaced with a new one. The licensee has also developed a new Quality Assurance form which will be exclusively used for Contura balloons and which incorporates the expected length for the five catheters. Department of Health Services (DHS) staff have been dispatched to investigate this incident.</br>Wisconsin Report Number: WI080017</br>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.necessarily result in harm to the patient.  
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00:00:00, 17 July 2008  +
025-1323-01  +
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02:14:00, 2 March 2018  +
12:05:00, 17 July 2008  +
3.295 d (79.08 hours, 0.471 weeks, 0.108 months)  +
05:00:00, 14 July 2008  +
Agreement State Report - Medical Event Due to Dose Less than Prescribed Dose  +
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