BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8165297 · Received December 14, 2018

    Report

    Report Number
    2029046-2018-02458
    Event Type
    Death
    Date Received
    December 14, 2018
    Date of Event
    November 4, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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) FOR THE LOT NUMBER 30073950M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. INITIALLY, IT WAS REPORTED THAT THE PATIENT¿S DATE OF DEATH WAS (B)(6) 2018. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THE DATE OF DEATH WAS EITHER (B)(6) 2018 OR (B)(6) 2018. CLARIFICATION HAS BEEN REQUESTED. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS DATE CLARIFICATION, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: NON-BIOSENSE WEBSTER, INC. PRODUCT - CIRCA SCIENTIFIC - CIRCA BIOTRONIK TEMPERATURE PROBE. BIOSENSE WEBSTER, INC. - CARTO® 3 SYSTEM CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A STOCKERT GENERATOR AND SUFFERED ESOPHAGEAL FISTULA, SEPSIS AND POSTERIORLY DIED. THE PERSISTENT PVI ABLATION WAS SUCCESSFUL. POST-PROCEDURE, AN ESOPHAGOSCOPY WAS DONE AS A STANDARD PROCEDURE IN THE HOSPITAL AND THERE WAS NO SIGN OF A DEFECT ON THE ESOPHAGUS. PATIENT WAS STABLE AND WENT HOME POST PROCEDURE. ABOUT ONE-MONTH POST-PROCEDURE, THE PATIENT WAS ADMITTED IN THE EMERGENCY ROOM WITH HIGH FEVER AND RETROSTERNAL PAIN. PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU). BROAD-SPECTRUM ANTIBIOTICS WERE ADMINISTERED. ESOPHAGOSCOPY WAS PERFORMED WHICH RESULTED IN THE DIAGNOSIS OF A SEPTIC EMBOLUS DUE TO AN ESOPHAGEAL FISTULA. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO RECEIVE TREATMENT AND POSTERIORLY DIED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ESOPHAGEAL FISTULA IS THAT IT WAS PROCEDURE-RELATED AND LINKED TO THE ANATOMICAL LOCATION OF THE ESOPHAGUS. PHYSICIAN MENTIONED THE PATIENT DIED AS A RESULT OF THE ESOPHAGEAL FISTULA. THE GENERATOR WAS USED IN POWER CONTROL MODE WITH A TEMPERATURE CUT-OFF AT 48 DEGREES CELSIUS. THERE WAS NO PERFORATION AT THE TIME OF THE PROCEDURE. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. A CIRCA "BIOTRONIC" TEMPERATURE PROBE AND ABLATION INDEX (AI) VALUE OF 300-400 WERE USED AS MODALITIES TO PREVENT ESOPHAGEAL INJURY. THE OVERALL TIME FOR ABLATION AND LAST ABLATION CYCLE TIME ARE UNKNOWN; HOWEVER, THERE WAS ONE SITE POST LEFT INFERIOR WHERE HIGH FORCE WAS USED, AND ABLATION INDEX SHOWED A VALUE ABOVE 500. IT IS UNKNOWN IF THAT LESION / LOCATION CONTRIBUTED TO THE FISTULA FORMATION. THE CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE FORCE VISUALIZATION FEATURES THAT WERE USED INCLUDED DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG INCLUDED RESPIRATORY GATED STABILITY: 3MM - 3 SEC; FOT 25% - 3G AND AI: ANT: 450-550 POST: 300-400. THE COLOR OPTIONS THAT WERE USED PROSPECTIVELY INCLUDED TIME AND AI. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 STATING THAT THE GENERATOR USED IN THIS PROCEDURE HAD ITS PREVENTIVE MAINTENANCE ON MAY 30, 2018. ACCORDING TO THIS REPORT, THE DEVICE IS FUNCTIONING PROPERLY. THEY HAVEN¿T HAD ANY ISSUES WITH THE GENERATOR SINCE THIS LAST PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005179 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30073950M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| H| R