Description of Event or Problem · 0
PRODUCT FAILURE CATEGORY, CARDIAC TAMPONADE. THERE WAS NO DEFECT NOR CAUSAL RELATIONSHIP TO THIS EVENT WITH THE DEVICES USED IN THE CARTO3. WHEN A LASER BALLOON WAS ATTEMPTED TO BE PLACED IN THE LSPV (LEFT SUPERIOR PULMONARY VEIN), THE BALLOON WAS ADVANCED WITH FLUOROSCOPIC CONFIRMATION, BUT IT WAS ACCIDENTALLY INSERTED INTO THE LAA (LEFT ATRIAL APPENDAGE), WHERE PERFORATION OF THE LAA (LEFT ATRIAL APPENDAGE) OCCURRED. DURING THE PROCEDURE, A BALLOON WAS PLACED IN WHAT WAS THOUGHT TO BE THE LSPV (LEFT SUPERIOR PULMONARY VEIN) AND BALLOON DILATION WAS PERFORMED. THE IMAGE SEEN ON THE ENDOSCOPE WAS VERY DIFFERENT FROM THE APPEARANCE AT THE LSPV (LEFT SUPERIOR PULMONARY VEIN), AND THE BALLOON WAS DEFLATED AND WITHDRAWN INTO THE LA AFTER A SUSPECTED MISPLACEMENT INTO THE LAA (LEFT ATRIAL APPENDAGE). IMMEDIATELY THEREAFTER, A SUDDEN DROP IN BLOOD PRESSURE AND WEAKENING OF THE BEATING OF THE CARDIAC SHADOW BY FLUOROSCOPY WERE OBSERVED. SINCE PERICARDIAL EFFUSION WAS CONFIRMED BY ACUNAV, PERICARDIAL DRAINAGE WAS PERFORMED WITH THE DIAGNOSIS OF CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).