VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Description of Event or Problem

THE PATIENT EXPERIENCED PERFORATION, HYPOTENSION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, CARDIAC ARREST AND CARDIOGENIC SHOCK. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION A VC CONNECT FARADRIVE 180P WAS SELECTED FOR USE. DURING PROCEDURE, UPON TRANSEPTAL ACCESS WITH VERSACROSS CONNECT SYSTEM AND WIRE, THE WIRE APPEARED ON FLUORO TO HAVE PERFORATED AND WAS OUTSIDE THE CARDIAC SILHOUETTE. PHYSICIAN THEN RETRACTED WIRE AND PERFORMED A SECOND TRANSEPTAL PUNCTURE WITH THE SAME DEVICE WITH BETTER POSITION, THE WIRE HAD POOR HANDLING AND FELT STUCK IN DILATOR HOWEVER THE FARADRIVE SHEATH WAS ADVANCED PER USUAL PROCEDURE AND THE PIGTAIL RF WIRE AND VERSACROSS CONNECT DILATOR WERE BOTH REMOVED IN NORMAL FASHION. DURING THE PVI ABLATION, IT WAS NOTED THAT PRESSURE WAS DROPPING. PHYSICIAN LOOKED AT ICE IMAGES AND NOTICED A PERICARDIAL EFFUSION. HE COMPLETED THE PVI AND THEN PERFORMED A PERICARDIALCENTESIS TO DRAIN THE EFFUSION. THIS SIGNIFICANTLY PROLONGED PROCEDURE TIME AS A LARGE AMOUNT OF FLUID WAS DRAINED OUT OF PERICARDIAL SPACE REPEATEDLY, THEN GIVEN BACK TO PATIENT VIA FEMORAL SHEATH. PATIENT ARRESTED DURING THIS TIME AND HAD CARDIOGENIC SHOCK, WHICH WAS TREATED WITH CPR. EVENTUALLY PATIENT STABILIZED- HOWEVER HE WAS TRANSFERRED TO ANOTHER FACILITY FOR MORE INTENSIVE CARE AND OBSERVATION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS. IT WAS FURTHER REPORTED THAT PATIENT ANATOMY DID NOT APPEAR ABNORMAL. TRANSEPTAL WAS PERFORMED UPON INITIAL POSITIONING OF VERSACROSS/FARADRIVE. VISUALIZATION OF WIRE WAS NORMAL. FLUORO AND ICE MODALITY WERE USED. ACT WAS 350 OR ABOVE. PHYSICIAN WAS UNDER THE IMPRESSION THAT PERF WAS THROUGH RIGHT ATRIUM ROOF. THE PATIENT WAS TRANSFERRED TO ADVENTHEALTH TAMPA. LAST UPDATE WAS THE PATIENT RECOVERED THERE AND WAS DISCHARGED HOME.