BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF NAV

    MDR report key: 21997774 · Received May 9, 2025

    Report

    Report Number
    2029046-2025-01501
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 14, 2025
    Report Date
    May 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS 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 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 · 0

    IT WAS REPORTED THAT AFTER COMPLETING AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A THERMOCOOL SF NAV (STSF) CATHETER, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, A PERICARDIAL EFFUSION (PE) TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED AFTER THE CASE WAS COMPLETED, AND WITH THE PATIENT'S BLOOD PRESSURE DROPPED AFTER THE PROCEDURE WAS COMPLETED. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH A CARDIAC ECHOCARDIOGRAM, AND THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE LAST KNOWN PATIENT STATUS WAS STABLE. A CARTO 3 SYSTEM WAS USED FOR MAPPING, AND A FARAPULSE AND NGEN SYSTEMS WERE USED FOR ABLATION. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT NO CARDIAC SURGERY REPORTED, AND THE PATIENT FULLY RECOVERED. THE EVENT WAS LIKELY RELATED TO FARAWAVE WIRE NOT BIOSENSE WEBSTER INC. (BWI) PRODUCTS, AND THE EVENT OCCURRED DURING ABLATION WITH FARAWAVE CATHETER. THE TRANSEPTAL DEVICE USED WAS A BAYLIS NRG, AND PRIOR TO NOTICING THE PE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. IRRIGATION WAS NOMINAL, AUTOMATIC FOR STSF SETTINGS. THE CORRECT CATHETER SETTING WAS SELECTED ON THE GENERATOR, AND THE PUMP SWITCHED FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. NO ERROR MESSAGE RELATED TO BWI PRODUCTS. FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, AND VECTOR, AND STABILITY PARAMETER USED WAS SURPOINT <450, ALL NOMINAL SURPOINT SETTING USED. NO ADDITIONAL FILTER WAS USED WITH VISITAG AND FTI COLOR OPTION WAS USED. THIS EVENT IS BEING CONSERVATIVELY REPORTED SINCE THE PE WAS NOTED AFTER THE CASE WAS COMPLETED. THUS, WE CANNOT RULE OUT THE BWI ABLATION CATHETER FROM CONTRIBUTING TO THE ADVERSE EVENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183313 THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L BAYLIS NRG.| CARTO 3 SYSTEM.| DUODECA CATHETER.| FARAPULSE SYSTEM.| NGEN RF GENERATOR, US.| NGEN SYSTEM.| OCTARAY CATHETER.| SOUNDSTAR CATHETER.