BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9250982 · Received October 29, 2019

    Report

    Report Number
    2029046-2019-03823
    Event Type
    Death
    Date Received
    October 29, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS RELATED TO THE SAME EVENT: (1) MFR # 2029046-2019-03823 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). (2) MFR # 2029046-2019-03824 FOR PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM RF GENERATOR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILATION (AFIB) ABLATION ON (B)(6) 2019 WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR DEVELOPED AN ESOPHAGEAL FISTULA AND SUFFERED DEATH. IT WAS REPORTED THAT THE PATIENT UNDERWENT A PAROXYSMAL AFIB ABLATION PROCEDURE ON (B)(6) 2019. POST PROCEDURE THE PATIENT DEVELOPED AN ESOPHAGEAL FISTULA. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) AND THE ESOPHAGEAL FISTULA WAS DIAGNOSED. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2019. ON 10/14/19 BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE PAROXYSMAL ATRIAL FIBRILATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2019. IT WAS REPORTED THAT THERE WAS NOTHING UNUSUAL DURING THE PROCEDURE. THEY USED AN ESOTEST ESOPHAGEAL MONITORING PROBE AND IT IS NOT UNUSUAL TO HAVE TEMPERATURE RISE AS THE PHYSICIAN WILL IMMEDIATELY COME OFF ABLATION AND WAIT TO ABLATE AGAIN WHEN IT COOLS DOWN. ON 10/24/19 BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE ADVERSE EVENT WAS DISCOVERED AFTER THE USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THE EVENT REQUIRED SURGICAL REPAIR OF THE ESOPHAGEAL FISTULA. PRE-PROCEDURE THE PATIENT¿S DIAGNOSIS WAS PAROXYSMAL AFIB. THE GENERATOR USED DURING PROCEDURE WAS A SMARTABLATE GENERATOR (SN: (B)(4)). NO SERVICING WAS REQUESTED FOR THE GENERATOR. THE OVERALL TIME (MINUTES AND SECONDS) FOR ABLATION AT THE SITE OF INJURY IS UNKNOWN. THE SMARTABLATE GENERATOR PARAMETERS WERE POWER CONTROL MODE, 20 WATTS WITH A 37C DEGREES CUTOFF. NO ERROR MESSAGES OBSERVED ON ANY BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. ESOPHAGEAL PROBE WAS USED TO MONITOR THE TEMPERATURE DURING THE ABLATION OF THE POSTERIOR WALL. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CONNECTION TO THE CARTO® 3 PIU. THE FORCE VISUALIZATION FEATURES THAT WERE USED WERE GRAPHY, DASHBOARD, VECTOR AND VISITAG. THE VISITAG MODULE WAS USED WITH THE FOLLOWING STABILITY SETTINGS: 2MM/3 SECS, FOT 25% 5GR, AND TAG INDEX. IN SUMMARY, ESOPHAGEAL FISTULA WAS DISCOVERED THREE WEEKS POST PROCEDURE AND THE PATIENT HAD EXPIRED DESPITE SURGICAL INTERVENTION. DURING THE PROCEDURE ESOPHAGEAL PROBE, REDUCED POWER (20 WATTS) ON THE POSTERIOR WALL AND 37 DEGREES CUT OFF WERE USED. THE FORCE WAS MONITORED USING THE VISITAG MODULE THAT WAS USED. THERE IS NO INDICATION THAT ANY SYSTEM MALFUNCTION HAD CONTRIBUTED TO THE EVENT, HOWEVER, BASED ON THE PROVIDED INFORMATION THE INVOLVEMENT OF BWI PRODUCTS CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047398 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| R ESOTEST ESOPHAGEAL MONITORING PROBE| SMARTABLATE GENERATOR KIT-WW