Description of Event or Problem · 1
THE PATIENT WAS IN THE OR FOR A SCHEDULED SURGICAL PROCEDURE THAT INCLUDED A MAZE PROCEDURE. THE SELECTED MAZE ABLATION MACHINE WAS THE CRYOCATH. DURING THE MAZE PROCEDURE, IT WAS NOTED BY THE DOCTOR THAT THE CRYOCATH FROSTBYTE CATHETER TIP WAS NOT FUNCTIONING CORRECTLY. NO COOLING/FREEZING WAS OCCURRING, AND THERE WAS A LOUD BLOWING SOUND COMING FROM THE DISTAL END OF THE DISPOSABLE HANDPIECE NEAR THE CRYOCATH MACHINE. THE ABLATION WAS STOPPED AND THEN RESTARTED WITH THE SAME OUTCOME, AND THEN THE CIRCULATING NURSE NOTICED THAT THERE WAS VERY COLD AIR (OR GAS) WAS BLOWING OUT OF THE END OF THE FROSTBYTE HANDPIECE CORD NEAR THE CRYOCATH MACHINE CONNECTION SITE. THE FROSTBYTE DISPOSABLE DEVICE WAS TAKEN OFF THE SURGICAL FIELD, AND DISCONNECTED FROM THE CRYOCATH MACHINE. AT THIS TIME, A HOLE APPROXIMATELY 1/2 INCH IN DIAMETER WAS NOTED ON THE UNDERSIDE OF THE CORD WHERE THE AIR WAS BEING RELEASED. A NEW DISPOSABLE CRYOCATH CATHETER WAS OPENED AND SET UP ON THE SURGICAL FIELD. THE EQUIPMENT WAS SET UP IN THE USUAL FASHION, AND THE TESTING PROCEDURE WAS STARTED. THE HANDPIECE DID NOT PASS THE TEST, WHICH WAS EVIDENT BECAUSE THE TEMPERATURE INDICATOR DID NOT REACH THE FREEZING TEMPERATURE NEEDED DURING ACTUAL ABLATION, AND THE TIME INDICATOR ON THE MACHINE WAS NOT SHOWING THAT THE ABLATION WAS TAKING PLACE, AS THE TIME CLOCK READ 0:00 DURING THE ENTIRE PRE-TEST. VIA TELEPHONE WITH CRYOCATH, A TECHNICIAN LED THE NURSE THROUGH SEVERAL TROUBLESHOOTING EXERCISES TO ATTEMPT TO GET THE EQUIPMENT TO FUNCTION PROPERLY. THE SURGICAL PROCEDURE WAS STOPPED AS A RESULT.