ENS 52793
ENS Event | |
|---|---|
15:40 Jun 7, 2017 | |
| Title | Agreement State Report - Dose to Patient Was Less than Prescribed Dose |
| Event Description | The following information was received from the State of Maine via email:
The following is a brief description of the event that occurred today in the [Maine Medical Center] (MMC) Cath Lab during an intravascular Brachytherapy (IVB) case. The source train was deployed to treat the 1st dwell position of the cardiac stent. Following delivery of the prescribed dose to the 1st dwell position the source train became stuck during return to the afterloader and could not be freed. This required complete removal of the catheter with the source train and placement of it in the bailout box. As a result, only 1 dwell position was treated causing the delivered dose to vary by more than 20 percent of the prescribed dose. The prescribed dose was 1840 REM. MMC does not have the exact delivered dose estimate, but it is approximately 50 percent of the prescribed [dose] because they had planned on 2 dwell positions. MMC will follow this up with a full written report as required by SMRRRP G.3045.D. The Licensee will be providing a full report to the State within 15 days as required. Maine Event Report: ME 17-003 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.
The following update excerpted information received from the State of Maine via email: A brief description of the event: During an IVB procedure the patient was intended to receive two dwells of radiation to cover a treatment area longer than the source train. After the first dwell position the source train become stuck in the catheter and did not properly retract to the after loader, when it was determined that the source was stuck (10-15 seconds), the catheter was pulled from the patient. The catheter, after loader, and source were placed in the bail-out-box. Only one of the two dwell positions was delivered. A survey of the room, the patient (was conducted to insure that source was removed from the patient), and the source was properly secured. The manufacturer, chief physicist, radiation safety and state radiation safety control were contacted. Why the event occurred: The reported complaint of failed hydraulic return of the Jacketed Radiation Source Train (JRST) to the Transfer Device (TD) was confirmed. The delivery catheter (DC) source lumen was found not passable by the JRST as a result of a deformation at 7.3 cm distal to the strain relief. The JSRT stopped location would have been outside the patient. The precise cause of the DC deformation is not known. The location and nature of the deformation suggest compression by a device or handling during intervention. Based upon available case information, the most likely scenario is compression of the catheter during a challenging advancement into a commonly tortuous vessel - the left internal mammary artery (LIMA). From published case reports in the literature, although successful in the majority of patients, percutaneous coronary revascularization of the left internal mammary artery using the transfemoral approach is usually a technically challenging procedure. Technical difficulties involved in LIMA intervention from the femoral approach stems from the acute angle between the proximal subclavian artery and the proximal left internal mammary artery. Thus, guide catheter support is often poor. In addition, the relatively long length and tortuosity of the LIMA (graft) make guidewire manipulation and balloon delivery difficult. These technical considerations magnify the difficulty of intervention. For these reasons, it is not unusual or unexpected that operators will experience difficulty advancing devices through the tortuous LIMA -including the distal mono-rail tip design Novoste B-rail delivery catheter. The potential for deformation of the catheter during advancement and navigability challenges in that artery is recognized. The Beta-Cath System User's Manual explicitly advises that the JRST may not navigate Internal Mammary (IM) guide catheters designed specifically for accessing left internal mammary arteries. Despite these challenges, the skilled operators in this case were able to successfully place the delivery catheter and deliver the JRST. In this case it is suspected that the DC source lumen deformation was very slight, not affecting movement during the sending of the JRST since the pressure is highest in the send lumen nearer to the device. However, the return hydraulic pressure is much lower behind the JSRT on return movement as it approaches the transfer device and was apparently not sufficient to overcome resistance of the dimensional interference. This hypothesis is consistent with the results of the method used to improve the source lumen for eventual hydraulic return of the JSRT. The effect, if any, on the individual(s) who received the administration: There was no effect on the patient. The patient is not excluded from receiving the additional course of intravascular brachytherapy, if restenosis and symptoms should occur. What action, if any, have been taken or at planned to prevent recurrence: Based on this event, no corrective actions are felt to be necessary. Certification that the licensee notified the individual and if not, why not: No notification was made to the patient. This decision was based on the Cardiologist's determination that the area of stenosis within the stent was covered by the 1st dwell position and the area did receive the prescribed dose of 18.4 Gy." Notified the R1DO (Arner), NMSS Events Notification |
| Where | |
|---|---|
| Maine Medical Center Portland, Maine (NRC Region 1) | |
| License number: | ME 05611 #27 |
| Organization: | Maine Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+21.02 h0.876 days <br />0.125 weeks <br />0.0288 months <br />) | |
| Opened: | Thomas Hillman 12:41 Jun 8, 2017 |
| NRC Officer: | Bethany Cecere |
| Last Updated: | Jun 23, 2017 |
| 52793 - NRC Website | |
Maine Medical Center with Agreement State | |
WEEKMONTHYEARENS 527932017-06-07T15:40:0007 June 2017 15:40:00
[Table view]Agreement State Agreement State Report - Dose to Patient Was Less than Prescribed Dose ENS 512482015-06-05T04:00:0005 June 2015 04:00:00 Agreement State Agreement State Report - Loss of I-125 Seed 2017-06-07T15:40:00 | |