VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION, AND PERFORATION. CARDIOTHORACIC SURGERY AND PERICARDIOCENTESIS WAS PERFORMED, AND THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION ABLATION, VERSA CROSS CONNECT FARADRIVE WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT PHYSICIAN WAS ATTEMPTING TO GAIN TRANSSEPTAL ACCESS INTO LEFT ATRIUM AND THE PHYSICIAN VISUALIZED VERSACROSS WIRE TENTING ON THE FOSSA OVALIS WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND PERFORMED SAFETY CHECKS BY LOOKING AT WIRE TRAJECTORY. PHYSICIAN USED POSITION TO CROSS INTO LEFT ATRIUM WITH VERSACROSS CONNECT FOR FARADRIVE SYSTEM IN CONJUNCTION WITH RF ENERGY DELIVERED BY GENERATOR. IT WAS CONFIRMED THAT THE VERSACROSS SYSTEM CROSSED INTO LEFT ATRIUM VIA VISUALIZATION OF BUBBLES ON ICE. PHYSICIAN NOTED DROP IN BLOOD PRESSURE AND CONFIRMED AN EFFUSION WITH ICE. THE PATIENT WAS ADMINISTERED EPINEPHRINE AND PERICARDIOCENTESIS WAS PERFORMED. CARDIOTHORACIC SURGERY WAS NEEDED TO REPAIR THE PERFORATION. THE PERFORATION OCCURRED AT LEFT ATRIAL APPENDAGE. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE AND IS EXPECTED TO FULLY RECOVER.