Event Notification Report for August 17, 2023
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/16/2023 - 08/17/2023
EVENT NUMBERS
56686
56686
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Hospital
Event Number: 56686
Rep Org: West Virginia University Hospital
Licensee: West Virginia University Hospital
Region: 1
City: Morgantown State: WV
County:
License #: 47-23066-02
Agreement: N
Docket:
NRC Notified By: Stephen Root
HQ OPS Officer: Karen Cotton-Gross
Licensee: West Virginia University Hospital
Region: 1
City: Morgantown State: WV
County:
License #: 47-23066-02
Agreement: N
Docket:
NRC Notified By: Stephen Root
HQ OPS Officer: Karen Cotton-Gross
Notification Date: 08/21/2023
Notification Time: 15:16 [ET]
Event Date: 08/17/2023
Event Time: 00:00 [EDT]
Last Update Date: 11/07/2023
Notification Time: 15:16 [ET]
Event Date: 08/17/2023
Event Time: 00:00 [EDT]
Last Update Date: 11/07/2023
Emergency Class: Non Emergency
10 CFR Section:
35.3045(a)(1) - Dose <> Prescribed Dosage
10 CFR Section:
35.3045(a)(1) - Dose <> Prescribed Dosage
Person (Organization):
Gray, Mel (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Gray, Mel (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
EN Revision Imported Date: 11/8/2023
EN Revision Text: MEDICAL EVENT - PATIENT UNDERDOSE
The following information was provided by West Virginia University Hospital via telephone and email:
"It was determined on 8/21/2023, that during a Y-90 (yttrium-90) Thera Sphere treatment performed on 8/17/2023, the delivered dose differed from the prescribed dose by more than 20 percent. The prescribed activity was 101.5 mCi and the administered activity was 3.4 mCi.
"At the start of the infusion the authorized user (AU) was unable to deliver the microspheres due to a blood clot in the microcatheter. The AU then decided to abort the infusion and reschedule instead of chancing potential contamination that could occur by changing out the microcatheter.
"The AU had completed the pre-treatment safety checklist with no issues. The AU has made the notification to the referring physician."
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.
* * * RETRACTION ON NOVEMBER 7, 2023, AT 1207 EST FROM WEST VIRGINIA UNIVERSITY HOSPITAL TO KAREN COTTON * * *
It was determined that the dose of yttrium-90 Thera Spheres was not delivered according to the written directive due to an emergent patient condition. Therefore, the incident does not qualify as a reportable medical event.
The patient's blood formed a clot within the microcatheter which prevented the passage of Y-90 microspheres. At the onset of administration, the Authorized User (AU) encountered significant resistance in the microcatheter, and they could not flush forward. When troubleshooting the delivery set, the AU visually identified the blood clot within the microcatheter. After several unsuccessful attempts to clear the blood clot, and in consultation with representatives from Boston Scientific, the AU decided to terminate the procedure. On September 1st, the Y-90 prescribed activity, as stated on the written directive, was successfully administered to the patient's hepatic artery. There were no adverse effects to the patient because of the underdose incident. The details of this incident were discussed with NRC inspectors who were on site for a reactive inspection. During those discussions it was concluded that since the patient's blood clotted within the microcatheter, the inability to complete the administration was due to an emergent patient condition.
The blood clot within the microcatheter was confirmed by an analysis of the delivery set performed by Boston Scientific's Product Analysis Team.
Notified: R1DO (Elise), NMSS Events Notification (E-mail)
EN Revision Text: MEDICAL EVENT - PATIENT UNDERDOSE
The following information was provided by West Virginia University Hospital via telephone and email:
"It was determined on 8/21/2023, that during a Y-90 (yttrium-90) Thera Sphere treatment performed on 8/17/2023, the delivered dose differed from the prescribed dose by more than 20 percent. The prescribed activity was 101.5 mCi and the administered activity was 3.4 mCi.
"At the start of the infusion the authorized user (AU) was unable to deliver the microspheres due to a blood clot in the microcatheter. The AU then decided to abort the infusion and reschedule instead of chancing potential contamination that could occur by changing out the microcatheter.
"The AU had completed the pre-treatment safety checklist with no issues. The AU has made the notification to the referring physician."
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.
* * * RETRACTION ON NOVEMBER 7, 2023, AT 1207 EST FROM WEST VIRGINIA UNIVERSITY HOSPITAL TO KAREN COTTON * * *
It was determined that the dose of yttrium-90 Thera Spheres was not delivered according to the written directive due to an emergent patient condition. Therefore, the incident does not qualify as a reportable medical event.
The patient's blood formed a clot within the microcatheter which prevented the passage of Y-90 microspheres. At the onset of administration, the Authorized User (AU) encountered significant resistance in the microcatheter, and they could not flush forward. When troubleshooting the delivery set, the AU visually identified the blood clot within the microcatheter. After several unsuccessful attempts to clear the blood clot, and in consultation with representatives from Boston Scientific, the AU decided to terminate the procedure. On September 1st, the Y-90 prescribed activity, as stated on the written directive, was successfully administered to the patient's hepatic artery. There were no adverse effects to the patient because of the underdose incident. The details of this incident were discussed with NRC inspectors who were on site for a reactive inspection. During those discussions it was concluded that since the patient's blood clotted within the microcatheter, the inability to complete the administration was due to an emergent patient condition.
The blood clot within the microcatheter was confirmed by an analysis of the delivery set performed by Boston Scientific's Product Analysis Team.
Notified: R1DO (Elise), NMSS Events Notification (E-mail)