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On January 2, 2013, the Agency (Texas Depa … On January 2, 2013, the Agency (Texas Department of State Health Services) was notified by the licensee that on December 4, 2012, a medical event had occurred. The licensee reported that while performing a therapy procedure using a Novoste Beta-Cath IVB device the last strontium-90 source in the ribbon of sources could not be retracted into the device. The source was jammed at the device entry port. All of the sources had been removed from the patient, therefore the patient did not receive any additional exposure. The device was placed into an emergency safety box designed for such events and the box was then covered with a lead apron. No one in the treatment room received any additional exposure form the event. The licensee will return the device to their supplier. Additional information will be provided as it is received in accordance with SA-300.</br>Texas State Report # I-9029</br>* * * UPDATE FROM ART TUCKER TO VINCE KLCO ON 2/21/2013 AT 1526 EST * * * </br>The following information was received by facsimile:</br>The Best Vascular Technical Team based in Norcross, Georgia evaluated the returned system that was involved in the subject complaint. The team confirmed the complaint based on the evidence of discoloration to the proprietary connector and acrylic body of the main chamber distal to the pin gate, indicating prolonged exposure to radiation; however upon arrival the Jacketed Radiation Source Train (JRST) was no longer stuck at the pin gate or proprietary connector of the delivery catheter. </br> </br>During testing, interlocks performed as expected to provide safety in the case of a manual removal. The team was unable to duplicate the complaint after exhaustive cycle testing. Visual examination identified a kink in the tubing leading to the fluid collection bag. </br> </br>A fluid sample that had been run through the transfer device and over the jacketed radioactive source train was analyzed for unsealed radiation; no radiation leakage was detected. </br> </br>Due to the size of the 3.5F delivery catheter, Best Vascular utilizes tubing materials that exhibit high column strength to ensure adequate trackability of the catheter during placement. The smaller size of the catheter is a desired feature that minimizes ischemia caused by cessation of blood flow during treatment. Unimpeded hydraulic flow is essential to performance of the system and as such, it is necessary to avoid the compression that may occur to the delivery catheter due to the configuration of the system in conjunction with other interfaces (e.g., interventional tools, patient, etc.). It is also essential that the path to the fluid collection bag be maintained in an unobstructed manner in order to provide the hydraulic pressure necessary for smooth movement of the JRST through the entire system.</br>Additional information on this event has been provided in the Nuclear Materials Event Database in accordance with SA-300.</br>Notified R4DO(Miller) and FSME via email.</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.
06:00:00, 4 December 2012 +
48,640 +
09:44:00, 2 January 2013 +
06:00:00, 4 December 2012 +
On January 2, 2013, the Agency (Texas Depa … On January 2, 2013, the Agency (Texas Department of State Health Services) was notified by the licensee that on December 4, 2012, a medical event had occurred. The licensee reported that while performing a therapy procedure using a Novoste Beta-Cath IVB device the last strontium-90 source in the ribbon of sources could not be retracted into the device. The source was jammed at the device entry port. All of the sources had been removed from the patient, therefore the patient did not receive any additional exposure. The device was placed into an emergency safety box designed for such events and the box was then covered with a lead apron. No one in the treatment room received any additional exposure form the event. The licensee will return the device to their supplier. Additional information will be provided as it is received in accordance with SA-300.</br>Texas State Report # I-9029</br>* * * UPDATE FROM ART TUCKER TO VINCE KLCO ON 2/21/2013 AT 1526 EST * * * </br>The following information was received by facsimile:</br>The Best Vascular Technical Team based in Norcross, Georgia evaluated the returned system that was involved in the subject complaint. The team confirmed the complaint based on the evidence of discoloration to the proprietary connector and acrylic body of the main chamber distal to the pin gate, indicating prolonged exposure to radiation; however upon arrival the Jacketed Radiation Source Train (JRST) was no longer stuck at the pin gate or proprietary connector of the delivery catheter. </br> </br>During testing, interlocks performed as expected to provide safety in the case of a manual removal. The team was unable to duplicate the complaint after exhaustive cycle testing. Visual examination identified a kink in the tubing leading to the fluid collection bag. </br> </br>A fluid sample that had been run through the transfer device and over the jacketed radioactive source train was analyzed for unsealed radiation; no radiation leakage was detected. </br> </br>Due to the size of the 3.5F delivery catheter, Best Vascular utilizes tubing materials that exhibit high column strength to ensure adequate trackability of the catheter during placement. The smaller size of the catheter is a desired feature that minimizes ischemia caused by cessation of blood flow during treatment. Unimpeded hydraulic flow is essential to performance of the system and as such, it is necessary to avoid the compression that may occur to the delivery catheter due to the configuration of the system in conjunction with other interfaces (e.g., interventional tools, patient, etc.). It is also essential that the path to the fluid collection bag be maintained in an unobstructed manner in order to provide the hydraulic pressure necessary for smooth movement of the JRST through the entire system.</br>Additional information on this event has been provided in the Nuclear Materials Event Database in accordance with SA-300.</br>Notified R4DO(Miller) and FSME via email.</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, 21 February 2013 +
00457 +
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02:01:43, 2 March 2018 +
09:44:00, 2 January 2013 +
29.155 d (699.73 hours, 4.165 weeks, 0.958 months) +
06:00:00, 4 December 2012 +
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