BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8081694 · Received November 16, 2018

    Report

    Report Number
    2029046-2018-02299
    Event Type
    Death
    Date Received
    November 16, 2018
    Date of Event
    October 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER ADDITIONAL INFORMATION THAT WAS RECEIVED FROM THE BIOSENSE WEBSTER REPRESENTATIVE ON NOVEMBER 27, 2018, THE BIOSENSE WEBSTER REPRESENTATIVE STATED THAT THE EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS NOT USED DURING THE PROCEDURE. SINCE THIS COMPLAINT ALREADY REPORTED TO THE FDA, THE IMPACTED PRODUCT FOR THE EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, THE CODING WILL REMAIN THE SAME. IN ADDITION, IT WAS ORIGINALLY REPORTED THAT DURING THE PASSAGE OF THE 4MM CATHETER, THERE WAS DIFFICULTY WITH THE DISSECTION OF THE TRUNK OF THE LEFT CORONARY AND ANGIOPLASTY WAS PERFORMED. AFTER SEVERAL ATTEMPTS AND USAGE OF TWO DIFFERENT CATHETERS, THE SURGEON DECIDED TO DESICCATE THE TRUNK OF CORONARY ARTERY. MYOCARDIAL INFARCTION OCCURRED, AND PATIENT PROGRESSED TO DEATH. HOWEVER, CLARIFICATION WAS RECEIVED ON NOVEMBER 27, 2018 STATING THAT ANGIOPLASTY WAS PERFORMED. AFTER SEVERAL ATTEMPTS AND USAGE OF TWO DIFFERENT CATHETERS, DISSECTION OF THE TRUNK OF CORONARY ARTERY OCCURRED. MYOCARDIAL INFARCTION SUBSEQUENTLY OCCURRED, AND PATIENT PROGRESSED TO DEATH. (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: 1. BIOSENSE WEBSTER, INC. PRODUCT - DECAPOLAR CATHETER , CATALOG #: UNKNOWN , LOT#: UNKNOWN . 2. BIOSENSE WEBSTER, INC. PRODUCT - PENTARAY NAV ECO CATHETER , CATALOG #: D128211 , LOT #: 17750491L . 3. BIOSENSE WEBSTER, INC. PRODUCT - 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

    INITIALLY, THIS COMPLAINT WAS ONLY REPORTED UNDER THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER UNDER 2029046-2018-02298 FOR (B)(4). HOWEVER, ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2018 STATING THAT A 4MM CATHETER WAS ALSO USED IN THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS PRODUCT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, THE ASSESSMENT WAS MADE TO REPORT THIS EVENT UNDER BOTH THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE 4MM CATHETER. SINCE PRODUCT INFORMATION HAS NOT BEEN PROVIDED FOR THE 4MM CATHETER, WE ARE REPORTING THIS PRODUCT UNDER A GENERIC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE AWARENESS DATE FOR THIS REPORT IS (B)(6) 2018. IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A BIOSENSE WEBSTER, INC. 4MM CATHETER AND SUFFERED MYOCARDIAL INFRACTION AND POSTERIORLY DIED. DURING THE PROCEDURE, THREE RIGHT-SIDED ARTERY PUNCTURES AND ONE FEMORAL VEIN WITH RADIOSCOPIC CONFIRMATION WERE PERFORMED, WITH 2 RF INTRODUCERS AND ONE 7RF. THE PHYSICIAN FACED ISSUES TO ACCESS THE LEFT VENTRICLE. THE DECAPOLAR CURVE CATHETER WAS POSITIONED IN THE CORONARY SINUS. THE PENTARAY AND SMART TOUCH CATHETERS WERE PLACED IN THE LEFT VENTRICLE. THE MAPPING OF VENTRICULAR ECTOPIES WAS THEN PERFORMED WITH PENTARAY CATHETER AND CARTO SYSTEM. DURING THE PASSAGE OF THE 4MM CATHETER, THERE WAS DIFFICULTY WITH THE DISSECTION OF THE TRUNK OF THE LEFT CORONARY AND ANGIOPLASTY WAS PERFORMED. AFTER SEVERAL ATTEMPTS AND USAGE OF TWO DIFFERENT CATHETERS, THE SURGEON DECIDED TO DESICCATE THE TRUNK OF CORONARY ARTERY. MYOCARDIAL INFARCTION OCCURRED, AND PATIENT PROGRESSED TO DEATH. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT¿S CONDITION AND A BAD FORMATION OF AORTIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920607 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE BN7TCDD4L, PMA # P990025/S12 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| L| R