Description of Event or Problem · 0
EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAD AN ADVERSE EVENT POST PROCEDURE. WHILE THE PATIENT WAS AWAKENED FROM ANESTHESIA AND EXTUBATED, THE PATIENT STOPPED BREATHING. THE PATIENT'S ELECTROCARDIOGRAM (ECG) "FLATLINED" SHORTLY AFTER RESPIRATION CEASED. EPINEPHRINE WAS GIVEN AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT WAS REINTUBATED AND A WEAK PULSE RETURNED. AFTER A FEW MINUTES, THE PATIENT'S HEART RATE AND BLOOD PRESSURE STABILIZED BUT THE PATIENT REMAINED INTUBATED. THE PROCEDURE WAS A PULSED FIELD ABLATION (PFA) WITH MEDTRONIC PULSESELECT¿. THE REPORTER STATED THAT WHILE ABLATING THE POSTERIOR WALL, THE PATIENT DID HAVE A COUPLE OF VAGAL RESPONSES WHILE RECEIVING ABLATION. THE REPORTER ALSO STATED THAT ABLATIONS WERE APPLIED OVER THE ESOPHAGUS. DURING THE PROCEDURE, THE PATIENT REMAINED STABLE. THE REPORTER STATED THAT THE PATIENT STOPPED BREATHING APPROXIMATELY TEN (10) MINUTES AFTER ALL THE CATHETERS HAD BEEN REMOVED FROM THE BODY. THE STAFF AND ANESTHESIA WERE PREPARING THE PATIENT FOR TRANSFER OFF THE X-RAY TABLE AT THE TIME OF THE EVENT. THE REPORTER NOTED THAT THE PATIENT CONTINUED TO BE INTUBATED AND STABLE ON TRANSFER TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER MONITORING. THE PHYSICIAN DID NOT PROVIDE ANY INFORMATION ON THE CAUSE OF THE CARDIAC ARREST AT THE TIME OF REPORTING. BWI CATHETERS USED DURING THE PROCEDURE: DECANAV (R7F282CT LOT 31628469M), 8FR SIEMENS SOUNDSTAR (10439011 LOT E8624104), OCTARAY CATHETER F CURVE 2-2-2-2-2 MM SPACING (D160904 LOT 31584996L) OCTARAY CATHETER IS RETAINED FOR RETURN. NON-BWI PRODUCTS: MEDTRONIC PULSESELECT¿ PFA CATHETER, MEDTRONIC FLEXCATH CONTOUR SHEATH, NRG BAYLESS TSS NEEDLE. CARTO SN (B)(6) SOFTWARE VERSION: 8.1.0.325. SMARTABLATE GENERATOR SN (B)(6) SOFTWARE VERSION: 1.7 CALLER REPORTS THAT THE GENERATOR WAS NOT USED DURING THE PROCEDURE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".