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 THAT A PERICARDIAL EFFUSION WAS NOTICED AT THE END OF THE PROCEDURE. THE CALLER REPORTED THAT THE PHYSICIAN BELIEVED THAT THE STRYKER REPROCESSED CS CATHETER CAUSED THE PERICARDIAL EFFUSION. THE CALLER REPORTED THAT WHEN THE FELLOW WAS PUTTING THE STRYKER CS CATHETER IN, THE STRYKER CS CATHETER WAS OBSERVED ON FLUORO IN AN ODD POSITION AND DEFLECTED INFERIORLY IN AN ODD POSITION. THE CALLER REPORTED THAT A SURFACE ECHOCARDIOGRAM WAS USED AT THE END OF THE PROCEDURE TO CHECK FOR A PERICARDIAL EFFUSION. THE CALLER REPORTED THAT THE PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED ON THE SURFACE ECHOCARDIOGRAM. THE CALLER REPORTED THAT THE PATIENT HAD NO VISIBLE SYMPTOMS. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND THAT 100-150 CCS OF FLUID WAS DRAINED. THE CALLER REPORTED THAT THE LAST KNOWN PATIENT STATUS WAS STABLE. THE CALLER REPORTED THAT THE OCTARAY CATHETER (D160904 / 31727499 - LOT NUMBER ON THE QR CODE) AND ABLATION CATHETER WERE AVAILABLE FOR RETURN. THE CALLER WAS ADVISED TO EXPECT A RETURN KIT FOR THE ABLATION CATHETER. SOFTWARE VERSION CONFIRMED (CARTO 3 SYSTEM - 13495) - 8.1.1.944 SOFTWARE VERSION CONFIRMED (NGEN GENERATOR) - UNKNOWN CSS JL WAS CONSULTED. CSS JL ADVISED TO DOCUMENT THE COMPLICATION UNDER THE ABLATION CATHETER. THE CALLER REPORTED THAT THE NGEN GENERATOR (23500271FG) WAS USED FOR ABLATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).