BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8081284 · Received November 16, 2018

    Report

    Report Number
    2029046-2018-02298
    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
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THIS COMPLAINT WAS ONLY REPORTED UNDER THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER UNDER 2029046-2018-02298 FOR MWR-01112018-0000232065. 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)(4) 2018. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. (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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 30026456M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. 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. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 20, 2018, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND 3 KINKS WERE OBSERVED ON THE SHAFT FROM 13" TO 16" STARTING FROM THE CATHETER HANDLE. THE FINDING IS DETERMINED TO BE NOT REPORTABLE. THE INTEGRITY MAINTAINED, AND NO INTERNAL COMPONENTS EXPOSED TO PATIENT. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. PER ADDITIONAL INFORMATION THAT WAS RECEIVED FROM THE BIOSENSE WEBSTER REPRESENTATIVE ON NOVEMBER 207, 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. PER THE ADDITIONAL CLARIFICATION RECEIVED, ADDED THE PATIENT CODE OF ¿DISSECTION¿ UNDER PATIENT CODES. INVESTIGATION SUMMARY CONCLUDED ON 12/12/2018. IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED VASCULAR DISSECTION, 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. 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. THE DEVICE WAS VISUALLY INSPECTED, AND KINKS WERE OBSERVED ALONG THE SHAFT. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, THE FORCE SENSOR WAS TESTED, AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, THE IRRIGATION AND DEFLECTION TEST WERE PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. 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. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE KINKS COULD BE RELATED TO THE HANDLING. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION 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
    919684 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30026456M 10846835009200

    Patients

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