BEUDAMED
    FDA Adverse Event Death Summary report: N

    NGEN GENERATOR

    MDR report key: 20797651 · Received November 27, 2024

    Report

    Report Number
    2029046-2024-03831
    Event Type
    Death
    Date Received
    November 27, 2024
    Date of Event
    September 24, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2. DATE OF DEATH - THE EXACT DATE OF DEATH IS UNKNOWN AT THIS TIME AND SO THIS FIELD WAS POPULATED WITH THE AWARENESS DATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING CLARIFICATION OF THE SYSTEM USED IN THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION, AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA. THE PATIENT DIED. THE PHYSICIAN WHO COMPLETED THE PROCEDURE WAS NOTIFIED BY A PHYSICIAN AT A DIFFERENT HOSPITAL THAT A PATIENT HAD PASSED AWAY AT THEIR LOCATION DUE TO A POSSIBLE INJURY CAUSED BY THE CATHETER ABLATION PROCEDURE. THE INJURY WAS REPORTED TO BE AN ESOPHAGEAL FISTULA. GENERATOR INFORMATION IS UNKNOWN. IT WAS REPORTED THAT "IT COULD HAVE BEEN A THERMOCOOL SMARTTOUCH® SF D-F CURVE OR F-J CURVE." THE EVENT IS BEING CONSERVATIVELY REPORTED UNDER THE ABLATION CATHETER AS THE EVENT REPORTED THAT THERMOCOOL SMARTTOUCH SF CATHETER MAY HAVE BEEN THE CATHETER USED. IN ADDITION, AS A CONSERVATIVE MEASURE, IT IS ALSO BEING REPORTED UNDER THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451962 NGEN GENERATOR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CARTO 3 SYSTEM| UNK_THERMOCOOL SF NAV