BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8093181 · Received November 20, 2018

    Report

    Report Number
    2029046-2018-02320
    Event Type
    Death
    Date Received
    November 20, 2018
    Date of Event
    October 25, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER (MODEL# D134805, LOT# 30076616L) CARTO 3 SYSTEM (MODEL# FG540000M, SN# (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH TWO THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS (STSF) AND SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION AND POSTERIORLY DIED. WHEN THE SYSTEM WAS SETTING AND BOOTED, CARTO 3 COULD NOT BE ADVANCED FROM ERROR 1. PATIENT INTERFACE UNIT (PIU) AND WORK STATION (WS) WERE REBOOTED SEVERAL TIMES BUT THE ISSUE CONTINUED. THE ISSUE WAS RESOLVED BY CHANGING THE OPTICAL CABLE BETWEEN THE PIU AND THE WS TO BACK-UP ONE. DURING THE PROCEDURE, A HEAVY NOISE OCCURRED AT THE DISTAL CHANNELS (MAP1-2) OF THE ABLATION CATHETER BEING DISPLAYED ON THE LAB. NOISE DID NOT OCCUR AT OTHER CATHETERS. THE CATHETER AND THE CABLE WERE CHANGED BUT THE ISSUE CONTINUED. WHEN THE MAP1-2 OF IC-OUT CABLE WAS RECONNECTED TO 3-4, THERE WAS A PROBLEM WITH MAP 1 CABLE. THE IC-OUT CABLE WAS CHECKED, AND IT WAS NOTICED THAT THE CABLE BASE WAS MISSING. THE PROCEDURE WAS COMPLETED BY WATCHING THE ABLATION TIP ELECTRODE INFORMATION ON THE CARTO 3 SCREEN. IT WAS ALSO REPORTED THAT WHEN THE STSF CATHETER WAS CONNECTED TO THE PIU, SENSOR ERROR 105 WAS DISPLAYED. THE CABLE WAS CHANGED BUT THE ISSUE REMAINED. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, THE PHYSICIAN CHECKED FOR PERICARDIAL EFFUSION WITH BS ECHOCARDIOGRAM. NO PERICARDIAL EFFUSION WAS OBSERVED. ON POST-PROCEDURE DAY 1, PATIENT¿S CONDITION WORSENED. THERE WAS A DROP-IN BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. AN EMERGENCY SURGICAL INTERVENTION WAS PERFORMED, AND A PULSATION MAINTENANCE DEVICE WAS IMPLANTED. AFTER OPERATION, THE PATIENT¿S CONDITION DID NOT IMPROVE. ON POST-PROCEDURE DAY 2, THE PATIENT DIED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. PHYSICIAN COMMENTED THE PHYSICIAN COMMENTED THAT DURING THE PROCEDURE THERE WERE TROUBLE EVENTS WITH THE BWI PRODUCTS. HOWEVER, AFTER THE ABLATION CATHETER WAS CHANGED, THERE WAS NO PROBLEM AND THAT THERE WAS NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE ADVERSE EVENT. THE ABLATION TIP ELECTRODE INFORMATION COULD NOT BE WATCHED IN THE LAB IT WAS WATCHED ON THE CARTO3. THERE WERE NO FACTORS CITED THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE GENERATOR WAS USED IN POWER CONTROL MODE DURING THE PROCEDURE. THE NOISE AND SENSOR ERROR 105 ISSUES HAVE BEEN ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930077 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30073293L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| L| R