BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16383393 · Received February 15, 2023

    Report

    Report Number
    2029046-2023-00300
    Event Type
    Death
    Date Received
    February 15, 2023
    Date of Event
    January 1, 2019
    Report Date
    February 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF DEATH AND DATE OF EVENT ARE UNKNOWN. PER THE EVENT DESCRIPTION, IT WAS REPORTED THAT THE PATIENT PASSED ASWAY IN 2019. THE PROCEDURE DATE IS UNKNOWN. THEREFORE, THESE FIELDS WERE POPULATED WITH THE FIRST DAY OF THE YEAR 2019. THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MANUFACTURE REPORT NUMBER FOR PRODUCT CODE D134804 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER) (2) IMPORTER REPORT NUMBER # 2029046-2023-50003 PRODUCT CODE UNK_SMARTABLATE GENERATOR (SMARTABLATE¿ SYSTEM RF GENERATOR (US))

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INCLUDED USE OF A SMARTABLATE GENERATOR AND A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED ESOPHAGEAL FISTULA. THE PATIENT SUBSEQUENTLY DIED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THE PHYSICIAN REPORTED A PATIENT WHO PASSED AWAY IN 2019 DUE TO AN ESOPHAGEAL FISTULA. THIS WAS POST ATRIAL FIBRILLATION ABLATION PROCEDURE. ADVERSE EVENT OCCURRED AFTER THE PATIENT HAD LEFT THE PROCEDURE. THE BWI REPRESENTATIVE REPORTED THAT HE IS UNAWARE OF THE DATE OF DEATH, AS WELL AS THE PROCEDURE DATE. THE BWI REPRESENTATIVE WAS MADE AWARE OF THIS EVENT ON (B)(6) 2023 AND MADE THE CALL FOR DOCUMENTATION PURPOSES. THE ADVERSE EVENT WAS DISCOVERED POST PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED. FORCE VISULAIZATION FEATURES INCLUDED DASHBOARD. VISITAG PARAMETERS FOR STABILITY WERE 2.5 MM, 6 SECONDS, FOT 25% FOR 3 GRAMS. ADDITIONAL FILTER USED WAS RESPIRATORY. COLOR OPTION WAS FTI LIMITED TO 400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354716 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134804 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death 6FR,10P,P,2-10-2,10PN-DR,120CM| LASSO NAV 2515,22P SPLITHANDLE| UNK TRANSSEPTAL NEEDLE| UNK_CARTO 3| UNK_SMARTABLATE GENERATOR