BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR

    MDR report key: 7571998 · Received June 5, 2018

    Report

    Report Number
    2029046-2018-01645
    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
    PMA / PMN Number
    P990071/S017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. 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 DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT: MFR # 2029046-2018-01644 FOR PRODUCT CODE D132705 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER). MFR # 2029046-2018-01645 FOR PRODUCT CODE M4900102 (SMARTABLATE GENERATOR).

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW ON JUNE 11, 2018, IT WAS NOTED THAT THE GENERATOR PRODUCT INFORMATION NEEDED CORRECTION. THE PRODUCT INFORMATION CORRECTED FROM ¿M4900102¿ TO ¿UNK_SMARTABLATE GENERATOR¿. THEREFORE, THE FOLLOWING FIELDS HAVE BEEN CORRECTED: CATALOG #:, UNIQUE IDENTIFIER( UDI):, BRAND NAME:, MANUFACTURING SITE NAME, MANUFACTURER SITE ADDR. STREET LINE 1, MANUFACTURER SITE ADDR. STREET LINE 2, MANUFACTURER SITE CITY, MANUFACTURER SITE ZIP CODE, MANUFACTURER SITE COUNTRY CODE, MANUFACTURER SITE POSTAL CODE. (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 425. 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
    413970 SMARTABLATE¿ SYSTEM RF GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

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