BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9586288 · Received January 14, 2020

    Report

    Report Number
    2029046-2020-00084
    Event Type
    Death
    Date Received
    January 14, 2020
    Date of Event
    December 18, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 70-YEAR-OLD MALE PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE ON (B)(6)2019 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA DEVICE IMPLANTATION) AND DEATH. ADDITIONAL INFORMATION WAS RECEIVED ON(B)(6)2020 INDICATING, THE PATIENT HAD MULTIPLE CO-MORBIDITIES, INCLUDING VENTRICULAR TACHYCARDIA (VT) AND A PRIOR LEFT VENTRICLE (LV) ANEURYSM REPAIR THAT LEFT A THINNING OF THE LV IN THE AREA OF WHERE THE PERICARDIAL EFFUSION OCCURRED. POST PERICARDIAL EFFUSION, MULTIPLE PROCEDURES AND SURGERIES WERE PERFORMED FROM WHICH THE PATIENT CONDITION DID NOT IMPROVE. THE CARTO 3 SYSTEM HAS BEEN UPDATES IN THE CONCOMITANT SECTION OF THIS REPORT. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE RANGE-2MM, TIME-3 SECONDS, FOT-25%, MINIMUM FORCE-3GM. RESPIRATORY ADJUSTMENT WAS USED AS ADDITIONAL FILTER. THE COLOR OPTION USED PROSPECTIVELY WAS TIME. THE INVESTIGATIONAL ANALYSIS COMPLETED (B)(6)2020. THE DEVICE WAS VISUALLY INSPECTED AND CHAR WAS FOUND ON THE TIP DOME .THE MAGNETIC, TEMPERATURE, AND FORCE FEATURES WERE TESTED. NO ISSUES WERE OBSERVED. THE CATHETER WAS DEFLECTING AND IRRIGATING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. CHAR IS A PHYSICAL PHENOMENON OF RADIO FREQUENCY. IT CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS. THE INSTRUCTIONS FOR USE STATE THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. MANUFACTURE REFERENCE NO:PC-(B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION, REDDISH-BROWN MATERIAL WAS OBSERVED ON THE PROXIMAL SIDE OF THE TIP DOME ON THE POLYURETHANE MARGIN. THE OBSERVED REDDISH-BROWN MATERIAL HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE ON (B)(6) 2019 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA DEVICE IMPLANTATION) AND DEATH. DURING THE ABLATION PHASE, PERICARDIAL EFFUSION WAS DISCOVERED ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGE IN THE LOWER RIGHT-HAND CORNER OF THE IMAGE ON THE CARTO 3 SYSTEM, AND THE EFFUSION APPEARED TO BE TOWARDS THE APEX. A STEAM POP WAS NOT NOTED NOR HEARD. HOWEVER, A SIGNIFICANT RUSH OF BUBBLES WAS NOTED PRIOR TO NOTING THE PERICARDIAL EFFUSION SO THE CALLER BELIEVED A STEAM POP MIGHT HAVE OCCURRED DURING THE CASE. HOWEVER, THIS INFORMATION WAS NOT CONFIRMED. CARDIAC TAMPONADE WAS CONFIRMED BY ICE. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT CONDITION DID NOT IMPROVE. THEREFORE, PROGRESSIVE AND AGGRESSIVE INTERVENTION UP TO ECMO WAS PROVIDED AND AN IMPELLA DEVICE WAS IMPLANTED. THE PATIENT WAS UNSTABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) ON ECMO FOR MONITORING. THE PATIENT STAYED IN THE ICU FOR ABOUT 1 WEEK. HIS HEALTH STATUS CONTINUED TO DECREASE AND ON (B)(6) 2019 THE PATIENT EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE CATHETER IRRIGATION WAS SET IN A CONTINUOUS FLOW AT 2ML, IN LOW POWER AT 8ML AND IN HIGH POWER AT 15ML. NO ERROR MESSAGES WERE OBSERVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48869 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 30270220M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| R CARTO 3 SYSTEM| CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US| CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US