BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10584629 · Received September 24, 2020

    Report

    Report Number
    2029046-2020-01338
    Event Type
    Death
    Date Received
    September 24, 2020
    Date of Event
    August 5, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/14/2020 IT WAS NOTICED THAT THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MEDWATCH REPORT: THE PATIENT WAS ABLATED ON AUGUST 5TH AND SHE WAS AWARE THAT ADDITIONAL ABLATION LESIONS WERE PERFORMED INCLUDING THE CORONARY SINUS AND SUPERIOR VENA CAVA. THE DOCTORS USES A TEMPERATURE PROVE AND A QUADRIPOLAR CATHETER SUTURED TO IT TO PROVIDE BOTH TEMPERATURE AND VISUALIZATION ON THE CARTO SYSTEM. THERE WERE NO REPORTS OF TEMPERATURE RISES DURING THIS CASE. AFTER THE PROCEDURE, THE PATIENT WENT TO HER HOME OUT OF STATE AND PRESENTED TO THE LOCAL EMERGENCY ROOM WITH FEVER AND WAS SENT HOME. SHE RETURNED WITH FEVER AND ALTERED MENTAL STATUS. A CT WAS PERFORMED WHICH DEMONSTRATED EVIDENCE FOR ESOPHAGEAL FISTULA AND DAYS LATER SHE PASSED AWAY. THIS WAS 2 WEEKS POST ABLATION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    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. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MANUFACTURE REPORT NUMBER FOR PRODUCT CODE D134804 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER), IMPORTER REPORT NUMBER # 2029046-2020-20005 PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM RF GENERATOR (US)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR ON (B)(6) 2020 AND SUFFERED ESOPHAGEAL FISTULA AND DEATH. SEVERAL WEEKS AFTER THE AFIB WAS COMPLETED, AN ESOPHAGEAL FISTULA WAS NOTICED. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH FEVER AND ALTERED MENTAL STATE. ESOPHAGEAL FISTULA WAS CONFIRMED BY COMPUTERIZED TOMOGRAPHY (CT). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. AN UNSPECIFIED INTERVENTION WAS PERFORMED; HOWEVER, THE PATIENT PASSED ON (B)(6) 2020. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE FISTULA IS THAT IT OCCURRED WHILE BURNING IN POSTERIOR WALL, PHYSICIAN BELIEVES THAT TEMPERATURE MONITORING WITH THE TEMPERATURE PROBE IN THE ESOPHAGUS WAS UNRELIABLE. PHYSICIAN DID NOT RECALL OR DOCUMENTED ISSUES WITH TEMPERATURE RAISES THAT LED HIM TO BELIEVE HE CANNOT COUNT ON THE TEMPERATURE FOR ACCURACY OF ESOPHAGEAL HEATING. THE SMARTABLATE¿ SYSTEM RF GENERATOR WAS USED IN POWER MODE WITH A TEMPERATURE CUT OFF AT 40 DEGREES, WARNING AT 37 DEGREES. TEMPERATURE MONITORING WAS DONE WITH ESOPHAGEAL TEMPERATURE PROBE. NO ERROR MESSAGES WERE DISPLAYED ON ANY SYSTEM. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 2MM STABILITY, 3, SECONDS, 3 GRAMS FOR 25% OF TIME. SURPOINT WAS USED AS ADDITIONAL FILTER AND COLOR OPTION WITH TARGETS 500 ON ROOF, AT 30 WATTS, 550 ANTERIOR 35-40 WATTS, AND 400 POSTERIORS AT 35 WATTS. THE IRRIGATION SETTINGS WERE: HIGH FLOW BETWEEN 8-15 ML/MIN, LOW FLOW AT 2 ML/MIN. PRE-RF TIME WAS 2 SECONDS AND POST-RF TIME WAS 5 SECONDS. THE IMPEDANCE SETTINGS WERE MAX IMPEDANCE OF 250 OHMS, SPIKE CUT OFF 25 OHMS, MIN CUT-OFF 50 OHMS AND POWER RAMP OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042848 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 Death| H| R CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| UNKNOWN ESOPHAGEAL TEMPERATURE PROBE| CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| UNKNOWN ESOPHAGEAL TEMPERATURE PROBE