BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGEN RF GENERATOR

    MDR report key: 23821099 · Received December 16, 2025

    Report

    Report Number
    2029046-2025-04164
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 20, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016109
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ON 26-JAN-2026 IT WAS NOTICED THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM SECTION H11. ADDITIONAL MANUFACTURER NARRATIVE OF THE 3500A SUPPLEMENTAL (FOLLOW-UP #1) MEDWATCH REPORT: ¿ON 7-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE ABLATION CATHETER USED DURING THIS PROCEDURE WAS A QDOT MICRO¿ CATHETER." AS SUCH, THE PMA DETAILS PREVIOUSLY REPORTED ARE CORRECT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    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. E1. INITIAL REPORTER PHONE: (B)(6). NOTE: 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 HAS BEEN PROVIDED. FOLLOW-UP IN PROGRESS. THEREFORE, WE ARE PROCESSING THIS MDR WITH THE "QDOT MICRO¿ CATHETER" WHICH IS THE MOST COMMONLY USED ABLATION CATHETER WITH THIS NGEN GENERATOR SYSTEM. NOTE: THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO NGEN RF GENERATOR APPROVED UNDER P210027. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN NGEN RF GENERATOR AND THEY HAD THE START BUTTON STUCK LEADING TO TWO (2) UNEXPECTED ABLATIONS. DEVICE EVALUATION DETAILS: TECHNICAL SERVICES DEPARTMENT PERFORMED REMOTE EVALUATION OF THE DEVICE. IT WAS DEEMED THAT THE START BUTTON WAS STUCK. AFTER A MONITOR REPLACEMENT, THE SYSTEM WAS FULLY OPERATIONAL. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF THE QUALITY PROCESS, THE DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN NGEN RF GENERATOR AND THEY HAD THE START BUTTON STUCK LEADING TO TWO (2) UNEXPECTED ABLATIONS. THE NGEN GENERATOR WAS USED IN ABLATION MODE OF QMODE+ WITH STANDARD SETTINGS. NO ABNORMAL TEMPERATURE, IMPEDANCE, AND POWER VALUES WERE OBSERVED. NO CUT OFF VALUES WERE EXCEEDED. NO PEDAL HAD BEEN USED AT THIS PROCEDURE THE SYSTEM DID NOT STOP AND STARTED TO ABLATE BY ITSELF WITH THE USER UNABLE TO STOP ABLATION USING THE STOP BUTTON. THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55827 NGEN RF GENERATOR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835016109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown