Description of Event or Problem · 0
PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6), INC. NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6), INC PRODUCT. IT WAS REPORTED BY THE CALLER THAT DURING AN AFIB PROCEDURE AN ADVERSE EVENT OCCURRED. THE CALLER STATED THAT THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE BAYLIS TRANSEPTAL NEEDLE INTO THE SUPERIOR VENA CAVA. THE CALLER STATED THAT THE PHYSICIAN FELT LIKE THEY HAD CROSSED THROUGH A PATENT FORAMEN OVALE BUT WHEN THEY LOOKED AT THE INTERATRIAL SEPTUM UTILIZING INTRACARDIAC ECHOCARDIOGRAPHY, THE BAYLIS TRANSEPTAL NEEDLE WAS NOT VISIBLE ACROSS THE SEPTUM. THE CALLER STATED THAT THEN THE PATIENT'S BLOOD PRESSURED DROPPED. THE CALLER STATED THAT A PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PATIENT. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THE FOLLOWING J&J MEDTECH ELECTROPHYSIOLOGY PRODUCTS WERE IN USE AT THE TIME OF THE INCIDENT: SOUNDSTAR® ULTRASOUND CATHETER: LOT NUMBER: UNKNOWN, REFERENCE NUMBER: UNKNOWN. EZ STEER WEBSTER CS CATHETER: LOT NUMBER: UNKNOWN, REFERENCE NUMBER: UNKNOWN. THE CALLER STATED THAT BOTH CATHETERS WERE AVAILABLE FOR RETURN AND WAS ADVISED TO EXPECT A RETURN KIT. NO OTHER DETAILS WERE AVAILABLE AT THIS TIME. BOSTON PFA FARAPULSE GENERATOR PLANNED FOR USE. CARTO 3 SYSTEM SOFTWARE VERSION 8.1.0.325. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5167700.