REPROCESSED DECANAV EP CATHETER, F CURVE

Additional Manufacturer Narrative

SINCE IT IS UNKNOWN WHICH SPECIFIC DECANAV CATHETER WAS IN THE PERICARDIUM, THE POSSIBLE LOTS ARE 2232562, 2232624 AND 2232574, WHICH HAVE THE SAME MANUFACTURE DATE (3/21/2025) AND EXPIRATION DATE (3/21/2027). D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. ALL THREE DEVICES 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 IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE DEVICE HISTORY RECORD FOR LOTS: 2232562, 2232624, 2232574 WERE REVIEWED AND THERE WERE NO IDENTIFIED MANUFACTURING DEFICIENCIES OR INTERNAL ACTIONS ¿ ALL FINISHED GOODS¿ DEVICES HAD PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO DISTRIBUTION. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED INTERNAL ACTIONS RELATED TO THE LOT OR REPORTED ISSUE. 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 AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A REPROCESSED DECANAV EP CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND CARDIAC SURGERY. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED DURING EPICARDIAL ACCESS. THE PATIENT HAD A DROP IN BLOOD PRESSURE MID-PROCEDURE. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAM AND FLUOROSCOPY. NO ABLATION HAD OCCURRED WHEN THE PERICARDIAL EFFUSION WAS NOTED. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND A CARDIOTHORACIC SURGEON ALSO "CRACKED THE CHEST" TO REPAIR A CARDIAC PERFORATION. WHEN THE CHEST WAS OPENED, THEY WERE ABLE TO VISUALIZE WHERE IT WAS BLEEDING, AND A GRAFT WAS PLACED ON THE CARDIAC PERFORATION IN THE RIGHT VENTRICLE. THE LAST KNOWN PATIENT STATUS WAS STABLE AND IN RECOVERY. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION TO MONITOR STATUS. THE PHYSICIAN BELIEVES THE CAUSE OF THE ADVERSE EVENT WAS A PROCEDURE COMPLICATION. THE EVENT OCCURRED DURING EPICARDIAL ACCESS. THREE REPROCESSED DECANAV CATHETERS WERE USED DURING THE CASE. EACH DECANAV WAS USED FOR A DIFFERENT PURPOSE. ALL THREE OF THE CATHETERS WERE FUNCTIONING PROPERLY. ONE DECANAV WAS PLACED IN THE CORONARY SINUS (CS), ONE WAS USED AS A PLACEHOLDER THROUGH THE EPICARDIAL SHEATH (TO PREVENT NAKED SHEATH), THIS CATHETER WAS IN THE EPICARDIAL SPACE, AND ONE WAS USED FOR ENDOCARDIAL MAPPING. THE FOLLOWING BIOSENSE WEBSTER INC. PRODUCTS WERE IN USE WHEN THE INJURY WAS NOTICED: THE QDOT CATHETER AND VIZIGO SHEATH WERE IN LV, AND A SOUNDSTAR CATHETER WAS IN THE RIGHT ATRIUM. A DECANAV CATHETER WAS IN THE CS AND ANOTHER DECANAV CATHETER WAS IN THE EPICARDIAL SPACE. AN OPTRELL CATHETER HAD BEEN IN THE LEFT VENTRICLE (LV) BUT HAD BEEN REMOVED BEFORE THE PERICARDIAL EFFUSION WAS NOTICED. IT IS UNKNOWN WHICH SPECIFIC DECANAV CATHETER WAS IN THE PERICARDIUM.

Additional Manufacturer Narrative

THIS IS A CORRECTION TO THE INITIAL REPORT. DURING INTERNAL REVIEW ON 18-MAR-2026, IT WAS DISCOVERED THAT THE MANUFACTURE DATE AND EXPIRATION DATE WERE INPUT INCORRECTLY INTO THE CORRESPONDING FIELDS. THAT HAS BEEN CORRECTED IN THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

CORRECTION TO INITIAL REPORT AS CONCOMITANT PRODUCTS WERE OMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).