BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGEN PUMP

    MDR report key: 23821800 · Received December 16, 2025

    Report

    Report Number
    2029046-2025-04166
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P990071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 PUMP APPROVED UNDER P990071. 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 THE NGEN¿ PUMP WAS IRRIGATING AT LOWER FLOW RATE THAN INDICATED. HARDWARE INVESTIGATION DETAILS: TECHNICAL SERVICES PERFORMED REMOTE EVALUATION OF THE DEVICE. WORK ORDER SERVICE REPORT WAS SENT TO JOHNSON & JOHNSON MEDTECH FOR ANALYSIS. IT WAS NOT DUPLICATED; LOW IRRIGATION FLOW RATE WAS RESOLVED BY REBOOTING THE NGEN PUMP. SYSTEM IS READY FOR USE. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONALLY, THE MANUFACTURED DATE HAS BEEN PROVIDED. THEREFORE, FIELD H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED. 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) ABLATION PROCEDURE WHERE A NGEN PUMP WAS USED. IT WAS REPORTED THAT THE NGEN¿ PUMP WAS IRRIGATING AT LOWER FLOW RATE THAN INDICATED. THEY RESEATED THE TUBING; HOWEVER, THE ISSUE REMAINED. WHEN THEY REBOOTED THE PUMP, THE ISSUE WAS RESOLVED AND THE CASE CONTINUED. THERE WAS NO ERROR DISPLAYED WHILE THE IRRIGATION WAS LOW. THE CATHETER WAS NOT INSIDE THE PATIENT WHEN THE LOW FLOW WAS OBSERVED. THE PHYSICIAN NOTICED A LOWER THAN USUAL FLOW WHEN FLUSHING THE CATHETER OUTSIDE THE BODY. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464002 NGEN PUMP CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRUPULSE GENERATOR, US.