BEUDAMED
    FDA Adverse Event Death Summary report: N

    NGEN GENERATOR

    MDR report key: 20516169 · Received October 23, 2024

    Report

    Report Number
    2029046-2024-03448
    Event Type
    Death
    Date Received
    October 23, 2024
    Date of Event
    August 13, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016109
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT, AS WELL AS THE CATALOG/MODEL NUMBER WERE NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION ON WHICH SYSTEM WAS USED DURING THIS PROCEDURE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THERE IS NO CLARIFICATION, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. SINCE NO SERIAL NUMBER WAS PROVIDED, NO MANUFACTURER RECORD EVALUATION COULD BE PERFORMED. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 22-JAN-2025. IT WAS REPORTED THAT THE PHYSICIAN'S OPINION ON THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK WITH UPPER GASTROINTESTINAL BLEEDING. ESOPHAGEAL INJURY WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. AS SUCH, THE CODE OF HEMORRHAGE/BLEEDING (E0506) WAS ADDED TO H 6. HEALTH EFFECT - CLINICAL CODE. PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 300. AN NGEN GENERATOR WITH QMODE PLUS WAS USED. NO ERROR MESSAGES DURING THE PROCEDURE. MODALITIES USED TO PREVENT ESOPHAGEAL INJURY WERE FORCE, IMPEDANCE AND XRAY. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. IRRIGATION WAS ON AUTOMATIC. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE FOLLOWING SECTIONS WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: CONCOMITANT PRODUCT SECTION, PATIENT INFORMATION SECTION, D 4. SERIAL, D 4. PRIMARY UDI NUMBER, H 4. DEVICE MANUFACTURE DATE WAS UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED. CORRECTION TO THE INITIAL REPORT: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. CORRECTION TO THE INITIAL: D 4. CATALOG WAS UPDATED AS THE PRODUCT CODE WAS PROVIDED. THE HARDWARE INVESTIGATION WAS COMPLETED ON 05-FEB-2025. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE WAS PERFORMED (WORK-ORDER, SERVICES PROVIDED, ETC.). HOWEVER, NO INFORMATION WAS OBTAINED. WITH THE INFORMATION AVAILABLE, IT CAN BE CONCLUDED THAT THE SERVICE WAS DECLINED. A HISTORICAL WORK ORDER REVIEW WAS PERFORMED FOR THIS DEVICE AND NO WORK ORDER REGARDING THIS COMPLAINT, OR ANY THAT COULD BE RELATED TO THE REPORTED EVENT WAS FOUND. 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. 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 A PULMONARY VEIN ISOLATION PROCEDURE, AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. A PATIENT DIED OF AN ESOPHAGEAL FISTULA A FEW DAYS AFTER PULMONARY VEIN ISOLATION WITH ADDITIONAL ROOF AND POSTERIOR LINE TRACTION. THE MEDICAL TEAM SUSPECTED THAT THE EXISTING AORTIC VALVE PROSTHESIS MAY HAVE BECOME HEATED DURING ABLATION OF THE POSTERIOR WALL, WHICH COULD HAVE CAUSED THE FISTULA TO FORM. HOWEVER, THEY ARE NOT CERTAIN. THE PATIENT ALREADY HAD SEVERAL PREVIOUS ILLNESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30322 NGEN GENERATOR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835016109

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death| L NGEN PUMP, EU CONFIGURATION| QDOT MICRO, UNI, TC, F| UNK TRANSSEPTAL NEEDLE| UNK_CARTO 3