ABLATION CONTROL SYSTEM

Description of Event or Problem

A MEDWATCH REPORT WAS RECEIVED FROM THE HOSPITAL STATING THE PT HAD A SURGICAL CARDIAC ABLATION USING AN ULTRACINCH AND ULTRAWAND DEVICE. FLUOROSCOPIC GUIDANCE WAS USED DURING THE PROCEDURE, WHICH CONFIRMED THE WAND AND THE CINCH WERE CORRECTLY PLACED. A TRANSESOPHAGEAL ECHO (TEE) HAD BEEN PERFORMED. THE PT EXPERIENCED DIFFICULTIES SWALLOWING POST OP AND WAS RE ADMITTED. A SWALLOW EXAM REVEALED EVIDENCE OF A LOCALIZED ESOPHAGEAL PERFORATION. A FEEDING THE TUBE WAS PLACED AND THE PHYSICIAN INDICATED THEY LET THE ESOPHAGUS REST. THE PT DID NOT REQUIRE SURGERY AND HAS FULLY RECOVERED. THE PHYSICIAN STATED HE DID NOT FEEL ANY OF THE EPICOR DEVICES CONTRIBUTED TO THE REPORTED EVENT. THE ULTRAWAND AND ULTRACINCH (UNK REORDER AND LOT) DEVICES ARE NOT AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

NONE OF THE COMPONENTS USED DURING THE PROCEDURE WERE RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED TRANSESOPHAGEAL PERFORATION REMAINS UNK. THE PHYSICIAN STATED HE DID NOT FEEL ANY OF THE EPICOR DEVICES CONTRIBUTED TO THE REPORTED EVENT. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: 2/10/2010.