BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8937394 · Received August 27, 2019

    Report

    Report Number
    2029046-2019-03582
    Event Type
    Death
    Date Received
    August 27, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON (B)(6) 2019. THE PATIENT¿S DEATH CANNOT BE RELATED TO THE IRRIGATION PUMP, THE PUMP WORKED DURING THE PROCEDURE WITHIN SPECIFICATION. DISPLAY ISSUE WAS IDENTIFIED BEFORE THE PROCEDURE STARTED AND WAS RESOLVED BY RE-STARTING THE SYSTEMS SEVERAL TIMES (GENERATOR, PUMP, AND REMOTE). NO FURTHER FAILURE OF THE DISPLAY NOTICED DURING THE ENTIRE PROCEDURE. THE PUMP ALWAYS SWITCHED BETWEEN THE DIFFERENT IRRIGATION RATES (2ML, 8ML, AND 15ML). IT ALSO GAVE BUBBLE ALARM AS WELL AS EMPTY BAG ALARM AT THE CORRECT POINT OF TIME SO THAT IT FUNCTIONED WITHIN SPECIFICATIONS. COMMUNICATION BETWEEN GENERATOR AND PUMP DID NOT SEEM TO BE IMPAIRED AT ANY TIME. ON 8/27/2019 AND 8/29/2019 ADDITIONAL CONCOMITANT PRODUCTS WERE PROVIDED. THEY WERE ADDED TO THE CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES" SECTION. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.  THE MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC ARREST REQUIRING REANIMATION, AND DEATH. DURING THE PROCEDURE, THE DISPLAY OF THE FLOW RATE WAS NOT ALWAYS SHOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO IMMEDIATE PATIENT CONSEQUENCES. HOURS POST-PROCEDURE, THE PATIENT CODED AND REQUIRED REANIMATION; HOWEVER, REANIMATION MANEUVERS WERE NOT SUCCESSFUL, AND THE PATIENT EXPIRED. THE PHYSICIAN WAS UNCLEAR ABOUT THE CAUSALITY OF THE EVENT; THEREFORE, HE ORDERED AN AUTOPSY. HE DID NOT FIND THE BIOSENSE WEBSTER, INC. PRODUCTS TO BE RELATED TO THE CAUSE OF THE ADVERSE EVENT. IT WAS STATED THAT ADDITIONAL INFORMATION WOULD BE PROVIDED WHEN THE AUTOPSY REPORT IS AVAILABLE. ON AUGUST 27, 2019, ADDITIONAL INFORMATION WAS RECEIVED THAT THE POSTMORTEM EXAMINATION WAS NOT COMPLETED; HENCE, THE EXACT CAUSE OF DEATH CANNOT BE CLEARLY CLARIFIED. THE PHYSICIAN HIMSELF ASSERTED ONCE AGAIN THAT IT CANNOT BE RELATED TO THE BIOSENSE WEBSTER, INC. PRODUCTS. THE ISSUE OF THE ¿DISPLAY OF THE FLOW RATE WAS NOT ALWAYS SHOWN¿ WAS ASSESSED AS NOT REPORTABLE AS IT WAS HIGHLY DETECTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE PATIENT¿S DEATH WAS ASSESSED AS MDR REPORTABLE. INITIALLY ONLY THE NOT REPORTABLE PRODUCT PROBLEM WAS REPORTED ON (B)(6) 2019; HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 9, 2019 PROVIDING THE ADVERSE EVENT. THEREFORE, THE AWARENESS DATE OF THE REPORTABLE ADVERSE EVENT IS AUGUST 9, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728466 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R 6FR CS,F,10 POLE,12 PIN,AUTOID| CARTO 3 SYSTEM| FIX 6F,4P,A,SD,5MM,12PN EEPROM| LASSO NAV 2515,22P SPLITHANDLE| SMARTABLATE GENERATOR KIT-WW| SMARTABLATE PUMP KIT-WW