RUSCH QUICK TRACH EMERGENCY CRICOTHYROTOMY DEVICE

Description of Event or Problem

WHEN FACED WITH AN AIRWAY FAILURE THAT COULD NOT BE RESOLVED WITH INTUBATION AS ALLOWED BY CURRENT PROTOCOL, AN ATTEMPTED WAS MADE TO USE THE QUICK TRACH EMERGENCY AIRWAY DEVICE. ON THE FIRST ATTEMPT, THE CRICOTHYROID MEMBRANE WAS LOCATED, THE DEVICE WAS INSPECTED TO ENSURE THE PROTECTIVE COVERING HAD BEEN REMOVED AND AN ATTEMPT TO PIERCE THE MEMBRANE WITH THE NEEDLE WAS MADE. DESPITE USING WHAT FELT LIKE EXCESSIVE PRESSURE, THE DEVICE WOULD ADVANCE. IMMEDIATELY, AN ASSISTING PARAMEDIC OPEN UP THE DETAILED ENCLOSED INSTRUCTIONS AND READ THROUGH THEM, THEN HAD THE ASSISTING PARAMEDIC READ STEP BY STEP AS ANOTHER ATTEMPTED WAS MADE, TAKING EXTRA CARE IN RELATION TO THE ADVISED PENETRATION ANGLE. AGAIN THE DEVICE WOULD NOT ADVANCE, DESPITE USING EVEN GREATER PRESSURE AND STABILIZING THE PATIENT'S TRACHEOSTOMY'S WITH A FREE HAND. AT THAT TIME MEDICAL CONTROL WAS CONTACTED, THE SITUATION WAS EXPLAINED AND THE DOCTOR WAS KEPT ON SPEAKERPHONE THROUGHOUT THE REMAINDER OF THE CALL. THE DOCTOR ADVISED FIRST STARTING BY PIERCING THE MEMBRANE WITH A LARGE BORE NEEDLE, THEN FOLLOW THROUGH THE PUNCTURE WITH THE DEVICE. THE NEEDLE ADVANCED EASILY. THE DEVICE QUICK TRACH WAS PLACED ALONGSIDE THE SPINE OF THE NEEDLE AND AN ATTEMPT TO ADVANCE THE DEVICE THROUGH THE PUNCTURE WAS MADE AS THE NEEDLE WAS REMOVED. AGAIN, DESPITE EVEN GREATER FORCE, THAT APPEARED TO BE STARTING TO COLLAPSE THE AREA, THE DEVICE WOULD NOT ADVANCE THROUGH THE CRICOTHYROID MEMBRANE. AT THIS TIME, UNDER THE DOCTORS ADVISE ATTEMPTS WITH THE DEVICE WERE DISCONTINUED AND ALTERNATIVE METHODS TO SECURE THE AIRWAY WERE MADE. FDA SAFETY REPORT ID# (B)(4).