Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A PFA ATRIAL FIBRILLATION CASE, THE PATIENT HAD PASSED AWAY. THEY HAD COMPLETED PFA ABLATION ON THE LEFT VEINS AND THE POSTERIOR WALL AND THEN MOVED ONTO ABLATE ON THE RIGHT SUPERIOR VEIN. AFTER APPLYING THE SECOND PFA LESION ON THE MIDDLE OF THE RIGHT SUPERIOR VEIN, IT WAS NOTICED ON THE CARTO¿ 3 AND RECORDING SYSTEM, THAT THE PATIENT HAD GONE INTO "VF" OR VENTRICULAR FIBRILLATION. THEY BEGAN TO ADMINISTER CHEST COMPRESSIONS TO THE PATIENT. IT WAS CONFIRMED THAT THERE WAS NO EFFUSION PRESENT IN THE PATIENT. THEY HAD CALLED A "CODE" FOR THE PATIENT. THE CALLER THEN REPORTED THAT THEY HAD TO LEAVE THE ROOM AT THIS POINT AND THE CALLER DID NOT HAVE ANY FURTHER EVENT DETAILS AVAILABLE. CONFIRMED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2025. THE CALLER STATED THAT THE PHYSICIAN SUSPECTS THE PATIENT MAY HAVE HAD AN "MI" OR MYOCARDIAL INFARCTION, BUT THE CALLER STATED THIS INFORMATION HAS NOT YET BEEN CONFIRMED. THE ACUSON ACUNAV¿ ULTRASOUND CATHETER WAS STILL IN THE BODY, WHEN THE PATIENT'S VF WAS NOTICED, BUT THE PENTARAY® NAV ECO CATHETER WAS NO LONGER IN THE BODY. THEY DID MAP WITH THE PENTARAY® NAV ECO CATHETER EARLIER IN THE PROCEDURE. THE FOLLOWING BWI DEVICES WERE ALSO IN USE: ACUSON ACUNAV¿ ULTRASOUND CATHETER THE CALLER STATED THAT THE ACUSON ACUNAV¿ ULTRASOUND CATHETER AND THE PENTARAY® NAV ECO CATHETER ARE NOT AVAILABLE FOR RETURN, AS THE ACCOUNT HAS REQUESTED TO RETAIN THEM FOR THE PATIENT'S AUTOPSY. FARAPULSE¿ SYSTEM WAS IN USE. XML SOFTWARE WAS IN USE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).