BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 23075775 · Received September 17, 2025

    Report

    Report Number
    2029046-2025-03192
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 27, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835002997
    PMA / PMN Number
    P990025/S12
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 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).

    Additional Manufacturer Narrative · 0

    NOTE: D4 FORM UPDATES WERE MADE AS THE LOT NUMBER HAD BEEN PROVIDED. D4 LOT NUMBER 31707728M. D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). ON 26-SEP-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. DURING AN AFAVRT/WPW ATRIAL FIBRILLATION ATRIOVENTRICULAR REENTRANT TACHYCARDIA / WOLFF-PARKINSON-WHITE SYNDROME) ABLATION WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, WHILE ATTEMPTING TO REGAIN TRANSSEPTAL ACCESS THE MEDICAL TEAM PERFORATED THE HEART. THE PATIENT CODED AND CPR WAS ADMINISTERED. A TRANSTHORACIC ECHO IDENTIFIED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT FULLY RECOVERED, AND THE LAST KNOWN STATUS WAS STABLE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND REVISION OF ALL DEVICE FEATURES WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE WAS CONNECTED TO CARTO 3 SYSTEM AND AN ABLATION CYCLE WAS PERFORMED; NO MAGNETIC, NOISE, TEMPERATURE OR IMPEDANCE ISSUES WERE FOUND. ADDITIONALLY, DEVICE WAS DEFLECTED DURING THE TEST AND NO ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 31707728M, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING RECOMMENDATIONS: WHEN USING THE CATHETER, USE CAREFUL CATHETER MANIPULATION IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT COMPLAINT WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    DURING AN AFAVRT/WPW ATRIAL FIBRILLATION ATRIOVENTRICULAR REENTRANT TACHYCARDIA / WOLFF-PARKINSON-WHITE SYNDROME) ABLATION WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, WHILE ATTEMPTING TO REGAIN TRANSSEPTAL ACCESS THE MEDICAL TEAM PERFORATED THE HEART. THE PATIENT CODED AND CPR WAS ADMINISTERED. A TRANSTHORACIC ECHO IDENTIFIED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT FULLY RECOVERED, AND THE LAST KNOWN STATUS WAS STABLE. JJMTEP PRODUCTS IN USE NGEN RF GENERATOR (UNKNOWN SERIAL NUMBER), CARTO 3 SYSTEM, EZ STEER 4MM NAV CATHETER (UNKNOWN LOT, PACKAGING DISPOSED OF), AND SOUNDSTAR GE 8 FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730405 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 31707728M 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CARTO 3 SYSTEM| NGEN RF GENERATOR, US| SOUNDSTAR ECO GE 8F CATHETER