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Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. THE PATIENT HAD A PERICARDIAL EFFUSION. AFTER OBTAINING TRANSSEPTAL ACCESS AND DELIVERING THE FIRST ABLATION LESION, THE CERTIFIED REGISTERED NURSE ANESTHETIST NOTED A MINOR DROP IN BLOOD PRESSURE. THE PHYSICIAN THEN SCANNED THE HEART VIA INTRACARDIAC ECHOCARDIOGRAM IMAGING WITH A SOUNDSTAR CATHETER AND NOTED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 700 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE STABLE AND PATIENT CONDITION HAS IMPROVED. PHYSICIAN¿S OPINION ON THE CAUSE OF THE ISSUE IS THAT THE PHYSICIAN INITIALLY THOUGHT IT WAS CAUSED BY THE TRANSSEPTAL ACCESS SINCE THERE WAS A "TOUGH" TRANSSEPTAL. DURING THE PERICARDIOCENTESIS, ONLY 100-200 ML OF FLUID WAS INITIALLY REMOVED. WHEN THE CS CATHETER WAS REMOVED FROM THE BODY, MORE FLUID WAS ABLE TO BE REMOVED. THE PHYSICIAN IS UNSURE WHETHER THE CS CATHETER HAD ANYTHING TO DO WITH THE EFFUSION. ONE ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION, THERE WAS NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN REPORTED AS DISCARDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. CORRECTION TO D4. PRIMARY UDI NUMBER, CORRECT UDI HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).