VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION, A NON-CONTRACTILE RIGHT VENTRICLE (RV), CARDIAC TAMPONADE, AND PERICARDIAL EFFUSION. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE RF WIRE WAS USED. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED, AND THE ABLATION PROCEDURE WAS PROCEEDING NORMALLY, BUT DURING ABLATION OF THE POSTERIOR WALL ERROR 301 PRE-PULSE FAILURE OCCURRED EIGHT TIMES ON THE GENERATOR. PULMONARY VEIN ISOLATION HAD BEEN COMPLETED BY THE TIME OF THE ERROR. IT WAS NOTED THAT THE CATHETER SPLINES WERE SEPARATED DURING THE ABLATION ATTEMPTS. THE PROCEDURE WAS SUSPENDED DUE TO THE GENERATOR ERROR, AND THE FARAWAVE CATHETER WAS REMOVED. AFTER THE PATIENT WAS CARDIOVERTED, HYPOTENSION PRESENTED AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED A NON-CONTRACTILE RV AND PERICARDIAL EFFUSION LOCATED ON THE POSTERIOR PART OF THE LEFT ATRIUM (LA). THE NON-CONTRACTILE RV WAS REVERSED WITH VASOACTIVE MEDICATIONS. PERICARDIAL DRAINAGE WAS PERFORMED FOLLOWED BY EMERGENCY SURGERY WITH CARDIOPULMONARY BYPASS (CPB). THE PATIENT WAS HOSPITALIZED AND IS EXPECTED TO FULLY RECOVER.

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. WHEN ANY FURTHER RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.