BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15541167 · Received October 4, 2022

    Report

    Report Number
    2029046-2022-02395
    Event Type
    Death
    Date Received
    October 4, 2022
    Date of Event
    July 11, 2022
    Report Date
    October 4, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MANUFACTURE REPORT NUMBER # FOR PRODUCT CODE UNK_SMART TOUCH BIDIRECTIONAL (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER); (2) IMPORTER REPORT NUMBER # 2029046-2022-50010 PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM GENERATOR (US)).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA AFTER THE PROCEDURE WHICH RESULTED IN THE PATIENT¿S DEATH. IT WAS REPORTED THAT WHEN THE BWI REPRESENTATIVE WALKED INTO THE ACCOUNT, THEY WERE NOTIFIED THAT A PATIENT THEY DID A POSTERIOR WALL ISOLATION PROCEDURE ON (B)(6) 2022, DIED APPROXIMATELY A WEEK LATER AT ANOTHER HOSPITAL. THE BWI REPRESENTATIVE WAS NOT THERE AT THE INITIAL PROCEDURE AND HAS NO INFORMATION ABOUT THE PROCEDURE. THE BWI REPRESENTATIVE WAS INFORMED ON (B)(6) 2022, ABOUT THIS EVENT WHICH HAPPENED AT LEAST 6-7 WEEKS EARLIER. FROM WHAT THE BWI REPRESENTATIVE UNDERSTOOD, THE PATIENT HAD AN ESOPHAGEAL FISTULA THAT CAUSED HER DEATH. NO ADDITIONAL PATIENT, PRODUCT OR PROCEDURE DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540232 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US