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Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR (AV) NODE ABLATION PROCEDURE WITH A REPROCESSED DAIG EP CATHETER SUPREME QUAD JOSEPHSON 262 AND THE PATIENT EXPERIENCED DROP IN BLOOD PRESSURE AND PERICARDIAL EFFUSION THAT WAS TREATED WITH PERICARDIOCENTESIS. DURING THE AV NODE ABLATION CASE, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, AND A PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED BY ULTRASOUND. THE PERICARDIAL EFFUSION WAS NOTICED AFTER USING OF THE REPROCESSED CATHETER (DAIG EP CATHETER SUPREME QUAD JOSEPHSON 262) ON THE RIGHT VENTRICLE. THE PHYSICIAN THINKS THAT THE CATHETER IN THE RV MAY HAVE CAUSED THE CARDIAC TAMPONADE. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS AND AT THE TIME THE PATIENT WAS REPORTED TO BE IN VERY STABLE CONDITION. THERE WERE NO CATHETER EXCHANGES DURING THE PROCEDURE, AND NO TRANSSEPTAL PUNCTURE PERFORMED DURING THE PROCEDURE. NO EVIDENCE OF STEAM POP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR, AND NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE PATIENT HAD SURGERY. PATIENT HAS RECOVERED AND DISCHARGED WITH NO FURTHER COMPLICATIONS.

Additional Manufacturer Narrative

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. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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).