WEBSTER

Additional Manufacturer Narrative

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 BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, 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 REFERENCE NUMBER: (B)(4).

Description of Event or Problem

DURING CARDIAC ABLATION PROCEDURE WITH A WEBSTER QUAD CATHETER, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) TREATED WITH CHEST COMPRESSIONS AND DEFIBRILLATION ABOUT 5-6 TIMES. THE LAST KNOWN STATUS OF THE PATIENT WAS THAT THEIR BLOOD PRESSURE WAS NORMAL, THEY WERE IN SINUS RHYTHM, AND A STAT ECHO WAS ORDERED. IT WAS REPORTED THAT WHILE STEMMING THE VENTRICLE TO SEE THE SEVERITY OF THE PATIENT'S VT (VENTRICULAR TACHYCARDIA), IT STARTED IN VT AND DETERIORATED INTO VF. THE PATIENT¿S BLOOD PRESSURE PLUMMETED, AND THE MEDICAL TEAM HAD TO CALL A CODE. THE PATIENT WAS ALREADY INTUBATED WHEN THEY NOTICED THE DROP IN BLOOD PRESSURE. THEY NOTICED THIS DUE TO THE 12LEAD BEING ALL VF AND WAS CONFIRMED ON X-RAY AND WITH THE QUAD CATHETER THAT WAS IN THE RIGHT VENTRICLE. THE ONLY KNOWN MEDICAL INTERVENTION PROVIDED TO THE PATIENT WERE CHEST COMPRESSIONS AND DEFIBRILLATION ABOUT 5-6 TIMES. THE ONLY BWI IN USE AT THE TIME WAS A QUAD CATHETER (FIX 6F,4P,A,SD,5MM,10PN-DR,115), CARTO 3 SYSTEM, AND PATCHES ON THE PATIENT. NO GENERATOR WAS IN USE, AND THE CASE WAS ABORTED. THE INFORMATION RECEIVED INDICATED THAT THE INTERVENTION PROVIDED WAS ANESTHESIA PROTOCOL. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PATIENT WAS UNDER GENERAL ANESTHESIA WITH TIME UNKNOWN. NO TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE CANCELLATION.

Additional Manufacturer Narrative

ON 21-JAN-2026, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31733851M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).