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 (B)(6), INC PRODUCT. IT WAS REPORTED THAT A PERFORATION IN THE LEFT ATRIUM OCCURRED DURING THE PROCEDURE. THE CALLER REPORTED THAT ANESTHESIA NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE UPON TRANSEPTAL ACCESS WITH THE FARADRIVE SHEATH. THE CALLER REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED USING ICE WHEN THEY SAW FLUID FORMING AROUND THE HEART. THE CALLER REPORTED THAT THE PROCEDURE WAS ABORTED. THE CALLER REPORTED THAT SOME ABLATION HAD BEEN PERFORMED WITH THE PFA CATHETER IN THE LEFT VEINS PRIOR TO THE PERICARDIAL EFFUSION BEING RECOGNIZED. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND THAT ABOUT 2300 ML OF BLOOD WAS REMOVED. THE CALLER REPORTED THAT THE PATIENT WAS TAKEN TO SURGERY FOLLOWING THE PERICARDIOCENTESIS AND THE PERFORATION WAS CONFIRMED. THE CALLER REPORTED THAT IT WAS UNKNOWN WHAT FURTHER MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT. THE PATIENT'S LAST KNOWN STATUS WAS REPORTED TO BE STABLE. THE CALLER REPORTED THAT THE THERAPEUTIC/DIAGNOSTIC BWI PRODUCTS IN USE WERE THE SOUNDSTAR CATHETER AND THE OCTARAY CATHETER. THE CALLER REPORTED THAT BOTH CATHETERS WERE DISCARDED. THE CALLER WAS UNABLE TO PROVIDE THE REFERENCE NUMBER AND LOT FOR THE CATHETERS. THE CALLER STATED THAT THE FARAPULSE SYSTEM WAS USED FOR ABLATION. THE CALLER STATED THAT PETAL XML WAS USED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).