Description of Event or Problem · 0
IT WAS REPORTED THAT A MALE PATIENT SUFFERED A PERFORATION IN THE LEFT ATRIAL APPENDAGE THAT CAUSED A PERICARDIAL EFFUSION. THEY PERFORMED A TRANSSEPTAL PUNCTURE WHILE USING THE BAYLIS NEEDLE AND TEE. THE PHYSICIAN EXCHANGED THE VIZIGO SHEATH FOR THE CARDIO FOCUS SHEATH AND WHILE MOVING THE BALLOON INTO THE LEFT SUPERIOR, THE PHYSICIAN NOTICED THERE WAS A DROP IN BLOOD PRESSURE. THE PATIENT WAS THEN TRANSPORTED TO THE OPERATING ROOM FOR AN INTERVENTION. THE PROCEDURE WAS ABORTED. THE PATIENT WAS ADMITTED. THERE WAS NO EVIDENCE OF ANY EFFUSION PRESENT BEFORE THE PROCEDURE. THERE WAS NO EVIDENCE OF A STEAM POP. BEFORE NOTING THE PERICARDIAL EFFUSION ABLATION WAS NOT PERFORMED. NO ERROR MESSAGES WERE OBSENED ON THE BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS LAST BALLOON - CARDIOFOCUS. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).