EN Revision Imported Date : 7/24/2019
EN Revision Text: AGREEMENT STATE REPORT - ADMINISTERED DOSE LOWER THAN PRESCRIBED DOSE
The following information was obtained from the State of Ohio via email:
"On October 16, 2018, a suspected medical event occurred. A patient was prescribed a dose of 120 Gy for segment 4 of the left lobe of the liver involving Y-90 TheraSpheres. All the pre-procedural safety checks were made and appropriate imaging (cone beam CT) was performed to check the catheter position and lesion location. During the first set of infusions, there was high resistance felt on the syringe which continued for the next few infusions. It was decided to stop the treatment as there was risk of inadequate delivery of the microspheres due to possibility of stasis and concern for non-target embolization to other sites. The residual was calculated and it was noted that estimated dose delivered was 6.4 Gy to the target lesion. Post-procedure, the patient had a PET CT to check the Y-90 microspheres distribution and it did not demonstrate any non-targeted deposition.
"The administered dose was 6.4 Gy to segment 4 of the left lobe of the liver. The dose was therefore 5% of the prescribed dose, a 95% difference.
"The microspheres not delivered to the target were contained in the catheter. No contamination occurred as a result of this event.
"The referring physician has been notified as well as the patient.
"A follow-up inspection will be conducted during the week of Oct. 22, 2018."
Ohio NMED Report No.: OH180010
* * * RETRACTION ON 7/23/2019 AT 1526 EDT FROM MICHAEL RUBADUE TO ANDREW WAUGH * * *
The following retraction was obtained from the State of Ohio via email:
"A follow-up inspection was conducted on October 24, 2018 to determine the circumstances leading up to this event.
"It was determined the difference in administered dose was due to emergent patient conditions and resistance of the patient's complex hepatic arterial system; stasis. There was no evidence of catheter misplacement, non-target disposition or mechanical failure of the Y-90 microsphere delivery system. There was also no evidence of any non-compliance with NRC guidelines or Ohio Administrative Code regulations."
Notified R3DO (Norton) and NMSS Events Notification (email).
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.