BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 21497636 · Received February 28, 2025

    Report

    Report Number
    2029046-2025-00614
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY 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 IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED ST ELEVATION, VENTRICULAR FIBRILLATION THAT RESULTED IN DEATH. DURING A PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION, AN STSF FJ CATHETER WAS USED TO MAP AND LOCALIZE THE PVC IN LVOT (LEFT VENTRICULAR OUTFLOW TRACT). CARTO 3D MAPPING WAS USED; HOWEVER, ICE (INTRACARDIAC ECHO) WAS NOT USED DURING THIS PROCEDURE. THE EARLIEST ACTIVATION WAS LOCALIZED IN THE LVOT JUST BELOW THE AORTIC CUSPS. ABLATION WAS PERFORMED ON THE EARLIEST SITE. AFTER ABLATION, THE PATIENT HAD ST ELEVATION, BLOOD PRESSURE DROPPED SEVERELY, AND PATIENT EVENTUALLY WENT INTO VF (VENTRICULAR FIBRILLATION). ECHO WAS DONE TO CHECK FOR EFFUSION/TAMPONADE. NEITHER WAS OBSERVED. A MECHANICAL PUMP WAS USED FOR CHEST COMPRESSIONS. AFTER NUMEROUS ATTEMPTS TO STABILIZE THE RHYTHM, THE PHYSICIAN EVENTUALLY CALLED IT AND THE PATIENT PASSED AWAY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO COMPLICATIONS FROM ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528409 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D| R UNK CARTO SYSTEM.