BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17712769 · Received September 8, 2023

    Report

    Report Number
    2029046-2023-02035
    Event Type
    Death
    Date Received
    September 8, 2023
    Date of Event
    August 6, 2023
    Report Date
    September 8, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 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 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. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MANUFACTURE REPORT NUMBER # 2029046-2023-02035 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). (2) IMPORTER REPORT NUMBER # 2029046-2023-50015 PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM RF GENERATOR (US)).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AF) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION REQUIRING CORONARY STENTING, CARDIAC TAMPONADE, CARDIAC ARREST AND ESOPHAGEAL FISTULA AND DEATH. A FEW DAYS AFTER AN AFIB CASE, THERE WAS A PATIENT DEATH. THE PATIENT WENT INTO THE HOSPITAL HAVING WHAT WAS SUSPECTED TO BE A HEART ATTACK, THEY STENTED HIS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE PATIENT WENT INTO CARDIAC ARREST. THEY DID A PERICARDIOCENTESIS AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THIS WAS ALL REPORTED BY THE HOSPITAL STAFF WHICH HAD ¿HEARD¿ OF WHAT HAPPENED BUT WERE NOT PRESENT DURING THE EVENT. THE PHYSICIAN LATER STATED THE CAUSE OF DEATH WAS RELATED TO AN ATRIAL ESOPHAGEAL FISTULA CAUSED BY AN AF ABLATION PROCEDURE. HE STATED THIS IS A PROCEDURAL COMPLICATION BUT NO AUTOPSY WAS PERFORMED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898419 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US