SIROS D-VIAL PREP SET

Description of Event or Problem

AT THE VERY END OF THE PROCEDURE, WHILE FLUSHING THROUGH THE D-LINE A FEW DROPLETS OF D5W WERE NOTICED ESCAPING THROUGH THE SEPTUM OF THE D-VIAL AND ROLLING OVER THE EDGE. NOTHING ESCAPED THE SIROS SYSTEM AND AFTER SURVEYING AND CONDUCTING THE POST PROCEDURE MEASUREMENTS THERE WAS ALMOST NO RESIDUAL AND OVER 100% OF THE WRITTEN DIRECTIVE WAS DELIVERED. WHATEVER MALFUNCTION OCCURRED IT DIDN'T HAPPEN UNTIL WE WERE DONE DELIVERING THE Y90 SPHERES BUT HAD THIS HAPPENED EARLIER IN THE PROCEDURE IT MAY HAVE BEEN A DIFFERENT STORY. I TOOK A SHORT VIDEO OF THE INCIDENT TO BETTER EXPLAIN WHAT HAPPENED AND CAN PROVIDE IT IF NECESSARY.

Additional Manufacturer Narrative

THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT AND THEY RECEIVED THEIR FULL DOSE. THE DEVICE WAS RETURNED TO SIRTEX FOR INVESTIGATION AND THE EVENT WAS NOT REPLICATED. A BATCH RECORD REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED.