ENS 54667
ENS Event | |
|---|---|
05:00 Apr 9, 2020 | |
| Title | Agreement State Report - Dose Not Delivered to the Correct Location During Brachytherapy Treatment |
| Event Description | 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. Device Information: 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 Treatment Information: 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. |
| Where | |
|---|---|
| Texas Dept Of State Health Services Houston, Texas (NRC Region 4) | |
| License number: | l-00457 |
| Organization: | Texas Dept Of State Health Services |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+148.33 h6.18 days <br />0.883 weeks <br />0.203 months <br />) | |
| Opened: | Karen Blanchard 09:20 Apr 15, 2020 |
| NRC Officer: | Thomas Kendzia |
| Last Updated: | Apr 15, 2020 |
| 54667 - NRC Website | |
Texas Department of State Health Services with Agreement State | |||||||
ENS 548912020-09-08T05:00:0008 September 2020 05:00:00 Agreement State | Agreement State Report - Lost and Recovered Camera ENS 548862020-09-05T05:00:0005 September 2020 05:00:00 Agreement State | Agreement State Report - Gauge Damaged When Struck by Vehicle ENS 548992020-09-01T05:00:0001 September 2020 05:00:00 Agreement State | Agreement State Report - Underdose During Medical Treatment ENS 548722020-08-31T05:00:00031 August 2020 05:00:00 Agreement State | Agreement State Report- Shutter Stuck in Open Position ENS 548662020-08-29T14:00:00029 August 2020 14:00:00 Agreement State Agreement State Report - Stolen Vehicle with Moisture Density Gauge ENS 548652020-08-28T05:00:00028 August 2020 05:00:00 Agreement State ENS 548622020-08-26T05:00:00026 August 2020 05:00:00 Agreement State ENS 548572020-08-24T05:00:00024 August 2020 05:00:00 Agreement State Agreement State Report - Nuclear Gauge Shutter Stuck Open ENS 548512020-08-21T13:00:00021 August 2020 13:00:00 Agreement State | ENS 548372020-08-13T05:00:00013 August 2020 05:00:00 Agreement State ENS 548152020-08-03T05:00:0003 August 2020 05:00:00 Agreement State Agreement State Report - Patient Underdose ENS 548102020-08-01T17:00:0001 August 2020 17:00:00 Agreement State Agreement State Report - Lost Moisture Density Gauge ENS 548052020-07-29T05:00:00029 July 2020 05:00:00 Agreement State Agreement State Report - Stuck Shutters ENS 547552020-06-23T14:00:00023 June 2020 14:00:00 Agreement State Agreement State Report - High Dose Rate Tandem Applicator Broken During Treatment ENS 547442020-06-09T05:00:0009 June 2020 05:00:00 Agreement State Agreement State Report - Stuck Shutter ENS 547302020-05-29T04:00:00029 May 2020 04:00:00 Agreement State Agreement State Report - Loss of Control of Radioactive Material ENS 547232020-05-21T05:00:00021 May 2020 05:00:00 Agreement State Agreement State Report - Stolen Moisture Density Gauge ENS 547062020-05-10T05:00:00010 May 2020 05:00:00 Agreement State ENS 546982020-05-07T05:00:0007 May 2020 05:00:00 Agreement State Agreement State Report - Damaged Nuclear Gauge ENS 546672020-04-09T05:00:0009 April 2020 05:00:00 Agreement State Agreement State Report - Dose Not Delivered to the Correct Location During Brachytherapy Treatment ENS 546232020-03-27T05:00:00027 March 2020 05:00:00 Agreement State Agreement State Report - Underdose of Patient Medical Event ENS 545862020-03-16T05:00:00016 March 2020 05:00:00 Agreement State Agreement State Report - Radiography Source Guide Tube Damaged ENS 545852020-03-13T05:00:00013 March 2020 05:00:00 Agreement State Agreement State Report - Patient Underdose ENS 545792020-03-10T05:00:00010 March 2020 05:00:00 Agreement State Agreement State Report - Stuck Open Shutter ENS 545532020-03-01T06:00:0001 March 2020 06:00:00 Agreement State Agreement State Report - Loss of Control of Radioactive Material ENS 545402020-02-24T06:00:00024 February 2020 06:00:00 Agreement State Agreement State Report - Stolen Density Gauge ENS 546262020-02-24T05:00:00024 February 2020 05:00:00 Agreement State Agreement State Report - Lost Static Control Device ENS 545342020-02-19T06:00:00019 February 2020 06:00:00 Agreement State Agreement State Report - Underdose of Yttrium-90 During Treatment ENS 545212020-02-11T06:00:00011 February 2020 06:00:00 Agreement State Agreement State Report - Qsa Exposure Device Open Shutter and Cap ENS 545112020-02-04T06:00:0004 February 2020 06:00:00 Agreement State Agreement State Report - Brachytherapy Source Failed to Retract ENS 544992020-01-29T06:00:00029 January 2020 06:00:00 Agreement State Texas Agreement State Report - Contamination Event Resulting in Restricted Access ENS 544862020-01-21T06:00:00021 January 2020 06:00:00 Agreement State Texas Agreement State Report - Stolen Moisture Density Gauge ENS 544822020-01-15T06:00:00015 January 2020 06:00:00 Agreement State Agreement State Report - Radiography Camera Source Disconnect ENS 544752020-01-12T06:00:00012 January 2020 06:00:00 Agreement State Agreement State - Fixed Gauge Stuck Shutter ENS 544562019-12-20T06:00:00020 December 2019 06:00:00 Agreement State Agreement State Report - Three Gauge Shutters Inoperable ENS 530082017-10-10T16:35:00010 October 2017 16:35:00 Agreement State Alarm System Breach 2020-09-08T05:00:00 [Table view] | ||