BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER NAV

    MDR report key: 25129176 · Received May 8, 2026

    Report

    Report Number
    2029046-2026-01522
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 8, 2026
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION AND THE PATIENT EXPERIENCED CARDIAC ARREST THAT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). AT THE END OF THE PROCEDURE, WHEN THEY REMOVED THE CATHETERS FROM THE PATIENT, THE SURFACE ECG SIGNALS ATTENUATED AND APPEARED TO BE FLAT LINED. THEY RESEATED THE ECG CABLE AND THE SIGNALS RETURNED. AT THE TIME OF THE OCCURRENCE, THEY HAD CHECKED FOR A PULSE AND THE ANESTHESIOLOGIST CONFIRMED THAT THE PATIENT DID HAVE A PULSE. THERE WAS NO INJURY TO THE PATIENT. UPDATED INFORMATION INDICATED THAT AFTER THE ABLATION PROCEDURE WAS CALLED BY THE PHYSICIAN, THE PHYSICIAN WITHDREW THE 4 CATHETERS (ABLATION RF, RV, CS, HIS) WITH THE 4MM NAVISTAR D/F AND QUAD CATHETERS FROM BWI, POLARIS - DECA FROM BOSTON SCIENTIFIC AND A CRD2 SUPREME FORM ABBOTT/ST. JUDE. A MEDTRONIC FREEZER CATHETER HAD BEEN USED FOR ONE APPLICATION WAS ALREADY REMOVED PRIOR AND WAS SITTING ON THE EXAM TABLE. IN LESS THAN 20 SECONDS OF WITHDRAWING THE CS CATHETER, THEY HAD AN EKG TRACING EVENT ON BOTH CARTO AND CARDIOLAB MONITORING SCREENS. AT FIRST, THE PHYSICIAN STATED THAT SHE DID NOT FEEL A PULSE (AT THE GROIN). THIS OCCURRED AS SHE STARTED FLUSHING THE ACCESS SHEATH. THE ANESTHESIOLOGIST STATED HE HAD AN ELECTROGRAM TRACING, WHEN A STAFF MEMBER (A REGISTERED NURSE) WAS HEADING TO THE TABLE SIDE TO PERFORM CPR. ABOUT 5-10 CPR COMPRESSIONS WAS ADMINISTERED. DURING THAT TIME, THE BS EKG CABLE TO THE PIU WAS UNPLUGGED, THEN RECONNECTED (AFTER 2-3 SEC WAIT) AND THE PRE-INCIDENT EKG TRACING REAPPEARED ON BOTH CARTO AND CARDIOLAB. ONE OF THE EP TECHNOLOGISTS CHECKED THE EKG CONNECTION TO THE PATIENT AND FOUND THE RL WAS "HALFWAY" ON THE PATIENT AND SHE PLACED A NEW ELECTROGRAM STICKER ON AND RECONNECTED THE EKG. BY THIS TIME, ALL CODE-LIKE THERAPY HAD STOPPED AND A REVIEW OF WHAT JUST HAPPEN, LED BY THE PHYSICIAN OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530529 EZ STEER NAV ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L