EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-F CURVE

Additional Manufacturer Narrative

THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 30-AUG-2022. THE DEVICE EVALUATION WAS COMPLETED ON 13-SEP-2022. THE PRODUCT WAS RETURNED TO STERILMED FOR EVALUATION. STERILMED PERFORMED VISUAL INSPECTION AND FUNCTIONAL TEST ON THE RETURNED DEVICE. A NON-STERILE REPROCESSED EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-F CURVE WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO ANOMALIES OR DAMAGES WERE OBSERVED ON THE DEVICE. THE TAG ID ATTACHED TO THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. THE DEFLECTION MECHANISM WAS TESTED, AND THE TIP OF THE DEVICE WAS CONFIRMED TO DEFLECT WITHIN SPECIFICATIONS. THE CATHETER WAS THEN CONNECTED TO THE CARTO 3 SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED WITHOUT ANOMALIES. NO ERRORS APPEARED ON THE SCREEN OF THE SYSTEM. LASTLY, THE CATHETER WAS TESTED FOR ELECTRICAL FUNCTIONALITY, AND ALL THE RESISTANCE VALUES WERE CONFIRMED TO BE WITHIN SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. AS PART OF STERILMED'S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CARDIAC TAMPONADE IS A KNOWN PROCEDURAL COMPLICATION ASSOCIATED WITH CARDIAC CATHETERIZATION PROCEDURES. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. ALL THE CATHETER FUNCTIONALITIES / FEATURES WERE SUBJECTED TO EVALUATION, AND THERE IS NO INDICATION THAT THE ISSUE ENCOUNTERED DURING THE PROCEDURE IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. WITH THE AMOUNT OF INFORMATION AVAILABLE, THE ROOT CAUSE OF THE CARDIAC TAMPONADE REMAINS UNKNOWN. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A 69-YEAR-OLD MALE PATIENT (110 KGS) UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB)ABLATION PROCEDURE WITH AN EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-F CURVE. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER THE ABLATION, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. IT WAS DISCOVERED WHILE THE PATIENT WAS STILL ON THE PROCEDURE TABLE, AFTER CATHETER REMOVAL, USING TRANSTHORACIC ECHO. THE CALLER WAS UNCERTAIN IF THE PATIENT'S BLOOD PRESSURE WAS AFFECTED. A PERICARDIOCENTESIS WAS ONGOING AT THE TIME OF THE CALL. THE PATIENT REMAINED STABLE. THE PHYSICIAN DID NOT INDICATE THAT THEY BELIEVED BIOSENSE WEBSTER, INC. PRODUCTS CONTRIBUTED TO THE PATIENT EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. PERICARDIOCENTESIS WAS PERFORMED, NO OTHER INTERVENTION NECESSARY. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN, BUT PATIENT WENT HOME. PATIENT STAYED IN HOSPITAL FOR 2 DAYS, WOULD HAVE ONLY BEEN HERE FOR THE DAY IF PROCEDURE WENT ACCORDING TO PLAN. TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WAS NO KNOWN STEAM POP. THE BIOSENSE WEBSTER REPRESENTATIVE IS NOT SURE WHEN THE EVENT OCCURRED, AS IT WAS NOTICED AFTER THE ABLATION WAS OVER. THE BIOSENSE WEBSTER REPRESENTATIVE SENT ALL CATHETERS BACK BECAUSE THEY WERE NOT SURE WHICH ONE WOULD BE UNDER INVESTIGATION AT THE TIME AND WANTED TO COVER ALL BASES. SINCE SENDING THEM BACK, THE PHYSICIAN HAS STATED SHE SUSPECTS SHE PERFORATED WITH THE CORONARY SINUS CATHETER AT THE BEGINNING OF THE CASE, BUT THEY WERE NEVER ABLE TO GET A DEFINITIVE DIAGNOSIS AS THE CHEST WAS NEVER OPENED. THE BIOSENSE WEBSTER REPRESENTATIVE DOES NOT KNOW WHICH CORONARY SINUS CATHETER IS THE SUSPECTED DEVICE. THEY THINK BOTH WERE USED IN AN ATTEMPT TO GET THE CORONARY SINUS ACCESS BUT CAN NOT REMEMBER THE ORDER THEY WERE USED IN. CONSERVATIVELY THE EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-F CURVE WAS ASSESSED AS MDR REPORTABLE AS ¿THE PHYSICIAN HAS STATED SHE SUSPECTS SHE PERFORATED WITH THE CORONARY SINUS CATHETER AT THE BEGINNING OF THE CASE, BUT THEY WERE NEVER ABLE TO GET A DEFINITIVE DIAGNOSIS AS THE CHEST WAS NEVER OPENED.¿ THEREFORE, IT IS DIFFICULT TO DETERMINE WHICH DEVICE CONTRIBUTED TO THE EVENT.