BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16908450 · Received May 10, 2023

    Report

    Report Number
    2029046-2023-00992
    Event Type
    Death
    Date Received
    May 10, 2023
    Date of Event
    March 9, 2022
    Report Date
    May 10, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND UNKNOWN SMARTABLATE GENERATOR . THE PATIENT EXPERIENCED AN ESOPHAGEAL FISTULA AND ULTIMATELY PASSED AWAY. ON (B)(6), THE SALES REP WERE MADE AWARE THAT A PATIENT THAT UNDERWENT AFIB ABLATION ON (B)(6) AND SUFFERED AN ADVERSE EVENT. PATIENT HAD AN ESOPHAGEAL FISTULA AND PASSED AWAY. THE DEATH OCCURRED ON THE NIGHT OF (B)(6) 2023. IN PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS OESOPHAGIAL FISTULA AND THE PROCEDURE. PATIENT PRESENTED TO THE ER WITH STROKE SYMPTOMS 1 MONTH AFTER AN AF ABLATION PROCEDURE. FORCE VISUALIZATION FEATURES WERE GRAPH, DASHBOARD, VECTOR, AND VISITAG. VISITAG PARAMETERS FOR STABILITY WERE USED (RANGE; TIME) 4MM 3SEC. ADDITIONAL FILTER USED WITH THE VISITAG WAS FTPI 400. COLOR OPTIONS WERE FTPI. GENERATOR PARAMETERS (POWER OR TEMPERATURE CONTROL MODE) AND THRESHOLDS (TEMPERATURE CUT OFF AND POWER CUT OFF): POWER CONTROL 40W. THE NOTED TEMPERATURE, IMPEDANCE, AND POWER AT THE TIME OF THE PERFORATION: 5 RF APPLICATIONS POSTERIOR/LEFT SIDE: - DURATION 11.30SEC, MD °C 20, IMPEDANCE 122-116, 40W - DURATION 18.45 SEC, MD °C 22, IMPEDANCE 133 ¿ 124, 40W - DURATION 13.15 SEC, MD °C 21, IMPEDANCE 128 ¿ 119, 40W - DURATION 16.55 SEC, MD°C 22, IMPEDANCE 130-124, 40W - DURATION 8.40 SEC, MD°C 21, IMPEDANCE 133-119, 40W MODALITIES WERE USED TO PREVENT ESOPHAGEAL INJURY: FTPI 400 / OESOPHAGIAL TEMP PROBE. ESOPHAGEAL INJURY CONFIRMED WITH CT SCAN / MRI. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. == GENERATOR INFORMATION. MAKE, MODEL, SERIAL NUMBER: SN (B)(4). MODEL M4900107. ALL DEATHS WERE BWI. FDA APPROVED ¿ CE MARK DEVICES ARE INVOLVED ARE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881993 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| D CARTO 3 SYSTEM| CARTO VISITAG MODULE| SMARTABLATE GENERATOR| UNSPECIFIED PUMP