Description of Event or Problem · 0
IT WAS REPORTED THAT DURING THE TRANSSEPTAL, WITH AN ACUTUS SHEATH AND NEEDLE, THE PHYSICIAN WAS NOT ABLE TO ASPIRATE THE SHEATH. THE SHEATH AND NEEDLE THEN "JUMPED" THROUGH THE SEPTUM. LATER, WHILE MAPPING THE LEFT ATRIUM WITH THE PENTARAY, THE PATIENT'S BLOOD PRESSURE DROPPED, AND PERICARDIA I EFFUSION WAS CONFIRMED BY ICE IMAGING. A PERICARDIOCENTESIS WAS PERFORMED, WITH 240 ML FLUID REMOVED. THE PROCEDURE WAS ABORTED. THE PATIENT IS CURRENTLY STABLE. BASED ON THE AVAILABLE INFORMATION, THE BWI DEVICES WILL BE CONSIDERED CONCOMITANT AS NO ABLATION WAS PERFORMED AND THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE TRANSSEPTAL SHEATH AND NEEDLE JUMPED FORWARD WHEN TRYING TO ASPIRATE THE SHEATH. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).