REPROCESSED ELECTROPHYSIOLOGY CATHETER

Description of Event or Problem

DURING A REDO SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED CARDIAC SURGERY TO STABILIZE THE PATIENT. THE TACTIFLEX ABLATION CATHETER WAS USED TO ABLATE ONE AREA THEN IT WAS DECIDED TO GO TRANSSEPTAL. THE PATIENT REPORTED ABDOMINAL DISCOMFORT. THE ICE CATHETER WAS INSERTED INTO THE RIGHT ATRIUM WHICH REVEALED A LARGE EFFUSION. ULTRASOUND MEASURED THE EFFUSION TO BE APPROXIMATELY 1.6 CM. WHEN THE MEASUREMENT INCREASED UP TO 2.4 CM, A PERICARDIOCENTESIS WAS PERFORMED, PROTAMINE WAS ADMINISTERED, FOLLOWED BY CARDIAC SURGERY. THE PERFORATION WAS LOCATED IN THE RIGHT VENTRICLE WHICH WAS NOTED TO BE VERY THIN AS THE SUTURES USED TO CLOSE THE PERFORATION WERE TEARING THROUGH THE TISSUE. WHEN PACING, MANEUVERING, AND ABLATING WITH THE ABLATION CATHETER IN THE HEART, THE IMPEDANCE NEVER INCREASED, EVERYTHING WAS CAPTURED APPROPRIATELY FROM THE DISTAL TIP, AND CONTACT FORCE NEVER EXCEEDED 40 GRAMS. THE PHYSICIAN STATED HE DIDN'T FEEL THE PERFORATION WAS CAUSED BY THE ABLATION CATHETER BUT FROM ONE OF THE DIAGNOSTIC CATHETERS WHEN INITIALLY PLACING THEM. THE PATIENT IS RECOVERING WELL AND HAS SINCE BEEN DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY OF THE (B)(6) PRODUCTS. THE DIAGNOSTIC CATHETERS WERE REPROCESSED BY STRYKER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5165794.