BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER THERMOCOOL

    MDR report key: 24865046 · Received April 13, 2026

    Report

    Report Number
    2029046-2026-01194
    Event Type
    Death
    Date Received
    April 13, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: 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. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. NOTE: FOR FIELD D4. CATALOG SHOULD BE ¿UNK_C3 EZ STEER THERMOCOOL SF NON-NAV¿. NOTE: FOR FIELD 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TYPICAL FLUTTER ABLATION PROCEDURE WITH AN EZ STEER THERMOCOOL AND THE PATIENT PASSED AWAY THE NIGHT AFTER THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE THE ABLATION CATHETER (EZ STEER THERMOCOOL) USED WAS CHANGED DUE TO "CATHETER TEMPERATURE ERROR", BUT THE NURSE IS UNSURE WHETHER THERE WAS ANY ABLATION PERFORMED WITH THIS CATHETER, OR IF IT WAS CHANGED BEFORE ABLATION BEGAN. THE SECOND ABLATION CATHETER (EZ STEER THERMOCOOL) WAS USED WITH NORMAL FUNCTIONALITY TO THE END OF THE PROCEDURE. NO BIOSENSE WEBSTER INC (BWI) REPRESENTATIVE WAS PRESENT DURING THE CASE AND IT WAS A SMARTABLATE GENERATOR AND FLUOROSCOPY ONLY; NO CARTO3 SYSTEM. ONLY THE CATHETER WITH THE REPORTED TEMPERATURE ERROR WAS PRESERVED, ALL OTHER DISPOSABLES WERE DISCARDED. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE CATHETER PROVIDED IN THIS COMPLAINT WAS NOT USED TO PERFORM ABLATION, IT WAS CHANGED OUT BEFORE ABLATION STARTED. THE CATHETER USED FOR THE ABLATION WORKED "AS NORMAL" ACCORDING TO THE HEALTH CARE PROVIDER. NOTHING SEEMED OUT OF THE ORDINARY WITH THE ABLATION PROCEDURE. NO FORCE-SENSING CATHETER WAS USED. ADDITIONAL DETAILS ARE UNKNOWN. THE CUSTOMER¿S REPORTED "CATHETER TEMPERATURE ERROR" WITH THE FIRST EZ STEER THERMOCOOL CATHETER IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917621 EZ STEER THERMOCOOL CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death