Description of Event or Problem · 0
PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, BIOSENSE WEBSTER, INC. NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) WEBSTER, INC. PRODUCT. IT WAS REPORTED DURING AN ATRIAL FIBRILLATION CASE; A PERICARDIAL EFFUSION WAS NOTICED. THE EVENT WAS NOTICED TOWARDS THE VERY END OF THE PROCEDURE. THEY ALSO DID A POSTERIOR WALL ISOLATION AND A ROOFLINE FOR AN A TYPICAL FLUTTER, AND A CTI IN THE RIGHT ATRIUM, DURING THE PROCEDURE. THE INJURY WAS NOTICED WHILE THEY WERE ABOUT TO PULL CATHETER BACK INTO THE RIGHT ATRIUM. ANESTHESIA NOTICED THERE WAS A SLIGHT DROP IN BLOOD PRESSURE ON THE PATIENT WHEN THEY TERMINATED THE FLUTTER. THE PHYSICIAN DID NOT NOTICE UNTIL 5-10 MINUTES LATER. THE PERICARDIAL EFFUSION WAS NOTICED ON THE INTRACARDIAC ULTRASOUND. THERE WAS TWO EXCHANGES BETWEEN THE OCTARAY CATHETER AND THE BOSTON SCIENTIFIC FARAPULSE BEFORE THE INJURY WAS NOTICED BY THE PHYSICIAN. THE INJURY WAS CONFIRMED THROUGH THE INTRACARDIAC ULTRASOUND AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THEY REMOVED ABOUT 200 CC'S OF FLUID FROM THE PATIENT. THEY WERE FINISHING UP NOW, THE PATIENT WAS STABILIZED AND APPROACHING BACK TO NORMAL. IT WAS UNKNOWN IF THE INJURY WAS CAUSED DURING MAPPING, ABLATION OR ANY EXCHANGE BECAUSE THERE WAS SOME TIME BEFORE THE INJURY OCCURRED AND WHEN IT WAS NOTICED. THE CALLER STATED WHEN THE INJURY WAS NOTICED, THERE WAS A SOUNDSTAR CATHETER INSIDE OF THE RIGHT ATRIUM AND THE OCTARAY CATHETER WAS IN AND OUT OF THE LEFT ATRIUM. THEY WERE STILL MONITORING THE PATIENT AT THE TIME OF THE CALL. FARAPULSE GENERATOR WAS IN USE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).