VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A FARAWAVE, FARAPOINT AND VERSACROSS CONNECT FARADRIVE WERE SELECTED TO USE FOR A FARAPULSE PROCEDURE. PROCEDURE PROCEEDED NORMALLY WITH NO NOTABLE INCIDENTS UNTIL, ON THE LEFT ATRIUM (LA) ACCESS, TO COME TO THE RIGHT SIDE FOR A CAVOTRICUSPID ISTHMUS (CTI) LINE WITH FARAPOINT, NO RESISTANCE FELT MANEUVERING THE CATHETER. FARAPOINT USE HAS NOT BEGUN WHEN ANESTHESIOLOGIST NOTED A DROP IN PRESSURE ON THE CUFF. PHYSICIAN CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND SAW A LARGE EFFUSION PRESENT, OCCURRED DURING THE PROCEDURE WHEN SHEATHS WERE WITHDRAWN FROM LA TO THE RIGHT ATRIUM FOR CTI FLUTTER, AN HOUR PASSED SINCE THE COMPLICATION WAS NOTED. INTRACARDIAC ULTRASOUND WAS PERFORMED TO VISUALIZE THE EFFUSION. CARDIAC TAMPONADE WAS ALSO REPORTED. PERICARDIOCENTESIS WAS PERFORMED AND PATIENT ULTIMATELY LANDED IN CT SURGERY. TO ADDRESS THE EVENTS A CARDIOTHORACIC (CT) SURGERY AND FURTHER HOSPITALIZATION WERE REQUIRED. CARDIAC SURGEON REPORTED A FINDING CLOT NEAR THE APEX SO IT WAS SURMISED THAT IT MAY HAVE BEEN THE NON-BOSTON SCIENTIFIC (BSC) CATHETER BUT COULD NOT LOCATE ANY PERFORATION TO FIX, SO CAUSE OF EFFUSION IS UNKNOWN. PATIENT WAS STABLE AND EXPECTED TO FULLY RECOVER AFTER SURGERY NO MORE PATIENT HEALTH STATUS IS AVAILABLE PER FACILITY. A NON-BSC GUIDEWIRE WAS USED AND NO RESISTANCE WAS FELT.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT AVAILABLE AT THE FACILITY.