BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGEN PUMP, US CONFIGURATION

    MDR report key: 19145070 · Received April 19, 2024

    Report

    Report Number
    2029046-2024-01304
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 26, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835017472
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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, THE CATHETER USED IN THIS CASE IS CURRENTLY UNKNOWN, THEREFORE NO PMA DETAILS ARE AVAILABLE. FOLLOW-UP WAS PERFORMED AND NO ADDITIONAL INFORMATION WAS PROVIDED. THEREFORE, THIS FILE IS PROCESSED WITH THE ABLATION CATHETER INFORMATION OF THE SMART TOUCH SF. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. 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

    ON 11-OCT-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). DEVICE EVALUATION DETAILS: THE S2 COMPONENT ON THE DISPLAY BOARD WAS DEFECTIVE AND WAS REPLACED TO SOLVE THE PROBLEMS. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 080223-114, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS. 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 ABLATION PROCEDURE WITH A NGEN PUMP, US CONFIGURATION AND THE MEDICAL TEAM EXPERIENCED AN ON-GOING LOW FLOW SETTING ISSUE. AFTER FAST FLUSHING THE PUMP, IT WILL NOT GO TO THE LOW FLOW SETTING. THE ISSUE WOULD BE RESOLVED ONLY AFTER REBOOTING THE PUMP BY UNPLUGGING AND REPLUGGING AND/OR DOING A POWER CYCLE. THE MEDICAL TEAM WAS ABLE TO CLEAR EVERY INSTANCE OF THIS ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057733 NGEN PUMP, US CONFIGURATION CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835017472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM.