BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGEN GENERATOR

    MDR report key: 22745866 · Received August 7, 2025

    Report

    Report Number
    2029046-2025-02619
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 17, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835018080
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON (B)(6) 2025, NOTED A CORRECTION TO THE 3500A FOLLOW-UP #1 AS SHOULD HAVE PROCESSED THE D10. CONCOMITANT MEDICAL PRODUCTS FIELD WITH THMCL SMTCH SF BID, TC, F-J. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IN THE 3500A INITIAL, UNDER H11. ADDITIONAL MANUFACTURER NARRATIVE, REPORTED: ¿PER FDA REQUEST, MDR SUBMISSIONS FOR THE NGEN RF GENERATOR ARE TO BE REPORTED WITH PMA DETAILS OF THE CATHETER USED ALONG WITH THE NGEN RF GENERATOR. HOWEVER, NO CATHETER INFORMATION WAS PROVIDED. FOLLOW-UP IS BEING PERFORMED AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THEREFORE, WE ARE PROCESSING THIS MDR WITH THE "QDOT MICRO¿ CATHETER" WHICH IS THE MOST COMMONLY USED ABLATION CATHETER WITH THIS SYSTEM.¿ HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 08-AUG-2025 PROVIDING THAT THE CATHETER USED ALONG WITH THE NGEN RF GENERATOR IN THIS PROCEDURE WAS THE THMCL SMTCH SF BID, TC, F-J. THEREFORE, THE NEW STATEMENT IS THE FOLLOWING: ¿PER FDA REQUEST, MDR SUBMISSIONS FOR THE NGEN RF GENERATOR ARE TO BE REPORTED WITH PMA DETAILS OF THE CATHETER USED ALONG WITH THE NGEN RF GENERATOR.¿ IN ADDITION, UPDATED THE FOLLOWING FIELDS: D2A. COMMON DEVICE NAME. D2B. PROCODE. G4. PMA/ 510(K). D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    PER FDA REQUEST, MDR SUBMISSIONS FOR THE NGEN RF GENERATOR ARE TO BE REPORTED WITH PMA DETAILS OF THE CATHETER USED ALONG WITH THE NGEN RF GENERATOR. HOWEVER, NO CATHETER INFORMATION WAS PROVIDED. FOLLOW-UP IS BEING PERFORMED AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THEREFORE, WE ARE PROCESSING THIS MDR WITH THE "QDOT MICRO¿ CATHETER" WHICH IS THE MOST COMMONLY USED ABLATION CATHETER WITH THIS SYSTEM. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN NGEN GENERATOR. IT WAS REPORTED THAT A FOOT PEDAL NOT CONNECTED ERROR (UNKNOWN ERROR CODE) WAS DISPLAYED ON THE NGEN MONITOR. WHEN INSPECTING THE NGEN FOOT PEDAL CONNECTION AT THE NGEN CONSOLE, THE PORT WAS NOTICED TO BE LOOSE. WHEN THE NGEN FOOT PEDAL CONNECTION WAS WIGGLED AT THE NGEN CONSOLE PORT, THE NGEN GENERATOR ERRONEOUSLY DELIVERED ABOUT 20 SECONDS OF ABLATION TO THE PATIENT EVEN THOUGH THE FOOT PEDAL OR START BUTTON WAS NOT PRESSED. THE STOP BUTTON WAS PRESSED TO STOP ABLATION. THE INVESTIGATION WAS COMPLETED ON 26-AUG-2025. TECHNICAL SERVICES PERFORMED A REMOTE EVALUATION OF THE DEVICE. WORK ORDER SERVICE REPORT WAS SENT TO JOHNSON & JOHNSON MEDTECH FOR EVALUATION. THE FOOT PEDAL ISSUE WAS DAMAGED, SO IT WAS REPLACED TO SOLVE THE PROBLEM (PART NUMBER M4900405 FOOT PEDAL). ALSO, IT WAS DEEMED THAT A CONSOLE FAILURE CAUSED THE SELF-ABLATION ISSUE. AFTER PART REPLACEMENTS, SYSTEM WAS WORKING AS INTENDED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF THE QUALITY PROCESS. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: INTEROPERABILITY PROBLEM IDENTIFIED (C04) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO COMPONENT FAILURE (D02) / COMPONENT CODE: FOOT PEDAL (G0408201) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿FOOT PEDAL¿ ISSUE. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿FOOT PEDAL ISSUE WAS DAMAGED¿. -INVESTIGATION FINDINGS: OPERATIONAL PROBLEM IDENTIFIED (C13)/ INVESTIGATION CONCLUSIONS: CAUSE TRACED TO COMPONENT FAILURE (D02) / COMPONENT CODE: HUB (G02021) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿ERRONEOUSLY DELIVERED ABLATION EVEN THOUGH THE FOOT PEDAL OR START BUTTON WAS NOT PRESSED¿. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿CONSOLE FAILURE¿. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN NGEN GENERATOR. IT WAS REPORTED THAT A FOOT PEDAL NOT CONNECTED ERROR (UNKNOWN ERROR CODE) WAS DISPLAYED ON THE NGEN MONITOR. WHEN INSPECTING THE NGEN FOOT PEDAL CONNECTION AT THE NGEN CONSOLE, THE PORT WAS NOTICED TO BE LOOSE. WHEN THE NGEN FOOT PEDAL CONNECTION WAS WIGGLED AT THE NGEN CONSOLE PORT, THE NGEN GENERATOR ERRONEOUSLY DELIVERED ABOUT 20 SECONDS OF ABLATION TO THE PATIENT EVEN THOUGH THE FOOT PEDAL OR START BUTTON WAS NOT PRESSED. THE STOP BUTTON WAS PRESSED TO STOP ABLATION. THE NGEN FOOT PEDAL WAS DISCONNECTED COMPLETELY FROM THE NGEN CONSOLE AND WAS DISABLED FROM THE NGEN MONITOR. THE PROCEDURE CONTINUED WITH MANUAL ABLATION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. GENERATOR WAS IN QMODE. TEMP/IMPEDANCE WERE DEFAULT SETTINGS. TIME CUTOFF 60 SECONDS. POWER SET AT 30W. THE TEMPERATURE, IMPEDANCE AND POWER VALUES WERE NOT NOTED. THE CUTOFF VALUES WERE NOT EXCEEDED. FOOT PEDAL WAS NOT STUCK. THE ABLATION WAS STOPPED BY USING THE RED STOP BUTTON ON THE MONITOR. THE FOOT PEDAL NOT CONNECTED ERROR CODE WAS ASSESSED AS NON MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE REPORTED, "WHEN THE NGEN FOOT PEDAL CONNECTION WAS WIGGLED AT THE NGEN CONSOLE PORT, THE NGEN GENERATOR ERRONEOUSLY DELIVERED ABOUT 20 SECONDS OF ABLATION TO THE PATIENT EVEN THOUGH THE FOOT PEDAL OR START BUTTON WAS NOT PRESSED,¿ WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497866 NGEN GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835018080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown THMCL SMTCH SF BID, TC, F-J.