IT WAS REPORTED WITH APPROX 25 SECONDS LEFT IN THE ABLATION USING THE UW-LP-2 ULTRAWAND, THE SURGEON HEARD AND FELT A POP THAT WAS FOLLOWED IMMEDIATELY WITH A SIZZLING NOISE. THE PHYSICIAN ASKED THE CIRCULATING NURSE TO PAUSE THE ABLATION AND THEN HE INSPECTED THE DEVICE. THE SURGEON NOTED THAT THERE WAS A SMALL HOLE IN THE MEMBRANE FOR ONE OF THE CELLS. IT WAS DEEMED AT THE TIME OF THE ERROR, THAT THE POP WAS CAUSED BY A LARGE AIR BOLUS THAT WAS CREATED DURING THE SWAPPING OF THE SALINE LINES FROM THE ULTRACINCH TO THE ULTRAWAND PORTION OF THE ABLATION SEQUENCE. THE CIRCULATING AND SCRUB NURSE THOUGHT THAT ALL OF THE AIR WAS DISCHARGED, ALTHOUGH AFTER THE INCIDENT DECIDED THAT AIR WAS STILL IN THE LINES. AS SOON AS THE SURGEON NOTED THE SOUNDS, THE TEMPERATURE WAS NOTED TO BE AROUND 50-55C. AFTER DISCUSSING THE EVENT, THE SURGEON ASKED THAT THE ABLATION BE CONTINUED FOR THE REMAINDER OF THE ABLATION SEQUENCE, WHICH OCCURRED WITHOUT FURTHER INCIDENT.
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Patient 1
ONE LP ULTRAWAND DEVICE WAS RETURNED FOR EVAL. VISUAL INSPECTION REVEALED NO DAMAGE TO THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. VISUAL INSPECTION REVEALED NO DEFECTS ON THE RETURNED DEVICE. FUNCTIONAL TESTING CONFIRMED THE DEVICE PASSED ALL IN-HOUSE TESTING. NO HOLES WERE FOUND IN EITHER MEMBRANE, OTHER THAN THOSE AS DESIGNED AND MANUFACTURED FOR SALINE PERFUSION. IT SHOULD BE NOTED THAT THE CIRCULATING NURSE AND SCRUB NURSE THOUGHT THAT ALL OF THE AIR WAS DISCHARGED, HOWEVER, AFTER THE INCIDENT, DECIDED AIR WAS STILL IN THE LINES. THE ULTRAWAND LP INSTRUCTIONS FOR USE INSTRUCT THE USER TO LOOK FOR AND REMOVE AIR BUBBLES. DATE REPORT SUBMITTED TO FDA BY MFR: 11/9/2009.