BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7572003 · Received June 5, 2018

    Report

    Report Number
    2029046-2018-01644
    Event Type
    Death
    Date Received
    June 5, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 8, 2018
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT: (1) MFR # 2029046-2018-01644 FOR PRODUCT CODE D132705 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER). (2) MFR # 2029046-2018-01645 FOR PRODUCT CODE M4900102 (SMARTABLATE GENERATOR).

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW ON (B)(6) 2018, IT WAS NOTED THAT THE RELATED GENERATOR PRODUCT INFORMATION REPORTED UNDER THE MANUFACTURER'S REFERENCE NUMBER 2029046-2018-01645 NEEDED CORRECTION . THE PRODUCT INFORMATION CORRECTED FROM ¿M4900102¿ TO ¿UNK_SMARTABLATE GENERATOR¿. MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ESOPHAGEAL FISTULA (REQUIRING A SURGICAL INTERVENTION) AND DEATH. SEVERAL DAYS POST-PROCEDURE (UNSPECIFIED), AN ESOPHAGEAL FISTULA WAS CONFIRMED VIA COMPUTED TOMOGRAPHY (CT). A STERNOTOMY WAS PERFORMED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT TO TREAT THE ESOPHAGEAL FISTULA. THE PATIENT EXPIRED. NO AUTOPSY WAS PERFORMED. MEDICAL HISTORY INCLUDES HYPERTROPHIC CARDIOMYOPATHY. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS RELATED TO THE ESOPHAGEAL FISTULA. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED AN ANY BWI PRODUCTS OR EQUIPMENT. SMARTABLATE GENERATOR WAS SET ON TEMPERATURE CONTROL MODE WITH TEMPERATURE CUT-OFF OF 50 DEGREES CELSIUS. POWER WAS SET AT 25 WATTS ON THE POSTERIOR WALL AND 30 WATTS ON THE ANTERIOR WALL. THERE IS NO FURTHER INFORMATION REGARDING GENERATOR PARAMETERS OR GENERATOR SETTINGS. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME AT THE SITE OF INJURY OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, AS THE PRECISE SITE OF INJURY IS UNKNOWN. ESOPHAGEAL INJURY PREVENTION MEASURES INCLUDED MAINTAINING THE ABLATION INDEX UNDER THE HIGH THRESHOLD. THERE IS NO INFORMATION REGARDING SPI VALUE OR CATHETER PROXIMITY. FORCE VISUALIZATION FEATURES INCLUDED GRAPH, DASHBOARD, VECTOR, AND VISITAG. VISITAG PARAMETERS FOR STABILITY INCLUDED RANGE 3 MM AND STABILITY 3 SECONDS. ADDITIONAL VISITAG FILTERS INCLUDED RESPIRATION. COLOR OPTIONS USED PROSPECTIVELY INCLUDE ABLATION INDEX WITH HIGH THRESHOLD OF (B)(6). THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED AN ANY BWI PRODUCTS OR EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414167 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. UNKNOWN 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| L| R