BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 20797705 · Received November 27, 2024

    Report

    Report Number
    2029046-2024-03832
    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
    LPB
    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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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
    2367448 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CARTO 3 SYSTEM| NGEN¿ RF GENERATOR