BEUDAMED
    FDA Adverse Event Death Summary report: N

    NGEN RF GENERATOR

    MDR report key: 18599012 · Received January 29, 2024

    Report

    Report Number
    2029046-2024-00319
    Event Type
    Death
    Date Received
    January 29, 2024
    Date of Event
    January 5, 2024
    Report Date
    May 1, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    P010068, P03
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 31-JAN-2024, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PREVIOUSLY REPORTED EVENT DATE OF 8-JAN-2024 IS ACTUALLY 5-JAN-2024. 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

    ON 16-APR-2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE CUSTOMER CONFIRMED THAT NO GENERATOR MALFUNCTIONS WERE REPORTED AND THAT SERVICING WAS NOT NEEDED FOR THE DEVICE. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER (B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. 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. THE CATHETER USED IN THIS CASE IS THE QDOT MICRO CATHETER. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS 2 REPORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A NGEN GENERATOR AND A QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE AND THE PATIENT EXPERIENCED POST-OP ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. THE COMPLICATION WAS DECLARED SEVERAL DAYS/WEEKS AFTER THE INTERVENTION. THE PHYSICIAN'S OPINION WAS THAT USE OF THE QDOT-MICRO CONTRIBUTED TO THE DEATH BUT DID NOT ELABORATE ON THE ISSUE. THE GENERATOR WAS IN TEMPERATURE CONTROL MODE WITH A TEMPERATURE CUT OFF OF 55°C. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. WHEN ASKED WHAT MODALITIES WERE USED TO PREVENT ESOPHAGEAL INJURY, THE PHYSICIAN RESPONDED WITH: "TEMPERATURE IN THE ESOPHAGUS". THE PHYSICIAN ALSO STATED THAT NO PERFORATIONS OCCURRED DURING THE PROCEDURE. THIS REPORT IS FOR THE NGEN RF GENERATOR. ANOTHER REPORT HAS BEEN SUBMITTED FOR THE QDOT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031639 NGEN RF GENERATOR CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC NGEN CONSOLE 2222 0022 DC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L CARTO 3 SYSTEM WITH VISITAG| NGEN PUMP, EU CONFIGURATION