NA

Additional Manufacturer Narrative

D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE DEVICE HAS BEEN REPORTED AS DISCARDED; THEREFORE, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PULSE FIELD ABLATION ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED WEBSTER CS (CORONARY SINUS) CATHETER, AND THE PATIENT EXPERIENCED PERFORATION TREATED WITH PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) POST-TRANSSEPTAL ACCESS. PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN REMOVING 130 ML OF FLUID. THE CASE WAS ABORTED. THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION TO MONITOR THE DRAIN OVERNIGHT. THERE WAS NO ABLATION PRIOR TO THE ADVERSE EVENT. THE CATHETERS INSIDE THE PATIENT WHEN THE PERICARDIAL EFFUSION WAS DISCOVERED WERE WEBSTER CS CATHETER AND REPROCESSED 8FR GE SOUNDSTAR CATHETER. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS CS PERFORATION, OPERATOR ERROR, AND PROCEDURE.