Advisor¿ HD Grid X¿ Mapping Catheter, Sensor Enabled¿

Description of Event or Problem

During an epicardial ventricular tachycardia (VT) ablation procedure in a patient with arrhythmogenic right ventricular cardiomyopathy (ARVC), a small laceration may have occurred in the epicardium, and the patient passed away three days later.Pericardial access was obtained via a subxiphoid approach to access the epicardial space using an Agilis Introducer. No issues associated with obtaining access were reported by the physician. The epicardium was mapped using an Advisor HD Grid X catheter. Following completion of mapping, the Advisor HD Grid X catheter was removed, and an ablation catheter was introduced in preparation for ablation of the basal anterior ventricular epicardium. Prior to delivery of ablation therapy, bleeding within the epicardial space was observed. Autotransfusion was initiated. The physician reported that a small epicardial laceration may have occurred either during epicardial access or during mapping; however, the source of the bleeding could not be definitively determined. After approximately 20 to 30 minutes, bleeding persisted despite the patient's vital signs remaining within acceptable limits. A surgical consultation was obtained, and a decision was made to proceed with surgical intervention to identify and repair the source of bleeding. Approximately 20 minutes later, the bleeding increased and the patient's blood pressure decreased to 60/30 mmHg. Cardiac arrest was declared, cardiopulmonary resuscitation (CPR) was initiated, and autotransfusion was continued while the patient was transported to the operating room.The patient died three days following the procedure.There were no performance issues with any Abbott device used during the procedure.