BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6639162 · Received June 13, 2017

    Report

    Report Number
    9673241-2017-00464
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 15, 2017
    Report Date
    May 15, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009002
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT SOME POINT DURING THE PROCEDURE, A CLOT WAS SUSPECTED, SO CORONARY ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED NO CLOTS AND NO OBSTRUCTIONS. IT WAS NOTED THAT IT WAS UNKNOWN PRECISELY WHEN VF OCCURRED. IT WAS DETERMINED THAT VF DID NOT OCCUR IMMEDIATELY UPON SIGNAL LOSS, BUT WAS ESTIMATED TO HAVE OCCURRED APPROXIMATELY 7-8 MINUTES LATER. PATIENT REQUIRED EXTENDED HOSPITALIZATION (A TOTAL OF 2 NIGHTS) AS A RESULT OF THE ADVERSE EVENT FOR ADDITIONAL TESTING. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. MEDICAL HISTORY INCLUDES (B)(6). PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO A BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTION. PHYSICIAN INDICATED THAT THERE MAY BE A CORRELATION BETWEEN THE CATHETER FAILURE AND THE VENTRICULAR FIBRILLATION. ONCE THE CATHETERS ENTERED THE PATIENT¿S BODY, THEY REMAINED ON THE RIGHT SIDE, AS NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED DURING THE PROCEDURE. IT WAS NOTED THAT THE CATHETER WAS UNABLE TO ABLATE AS A RESULT OF A LOSS OF ENERGY. THERE IS NO FURTHER INFORMATION REGARDING THIS ISSUE. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. THE STUDY WAS NOT INITIALIZED, THEREFORE, NO FORCE VISUALIZATION, VISITAG PARAMETERS FOR STABILITY, ADDITIONAL VISITAG FILTERS, OR COLOR OPTIONS WERE USED. SINCE THE PATIENT'S HEART RHYTHM WAS NOT VISIBLE TO THE OPERATOR AND THE LACK OF MONITORING OF CARDIAC RHYTHM WHILE DEVICES ARE INTRACARDIAC MIGHT LEAD TO UNDETECTED CARDIAC RHYTHM THAT CAN BE LIFE THREATENING, WE ARE REPORTING THIS SIGNAL ISSUE UNDER BOTH THE C3 INTERFACE CABLE ¿ THERAPEUTIC AND THE THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4); COOL FLOW PUMP, MODEL #: M-5491-01, SERIAL #: (B)(4); EP - SHUTTLE RF GENERATOR SYSTEM - 100W, MODEL #: 39D-76X, SERIAL #: (B)(4); NON-BWI PRODUCTS - ST. JUDE MEDICAL SL0 SHEATH. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17645963M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ON JUNE 14, 2017 WE NOTED A CORRECTION NEEDED TO ¿EVENT TYPE¿. IN THE INITIAL IT WAS PROCESSED AS ¿ADVERSE EVENT¿. THE CORRECT TYPE IS ¿AE AND PP¿. EVENT TYPE HAS BEEN CORRECTED TO REFLECT ¿AE AND PP¿. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER AND A C3 INTERFACE CABLE ¿ THERAPEUTIC SUFFERED VENTRICULAR FIBRILLATION REQUIRING ELECTRICAL CARDIOVERSION AND CORONARY ANGIOGRAPHY. DURING THE PROCEDURE, THE SHORT INTRODUCERS WERE PLACED. CORONARY SINUS (CS) CATHETER WAS POSITIONED IN THE CS. THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER WAS POSITIONED ON THE ICT (UNDEFINED). PER THE PHYSICIAN, THE THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER WAS NOT POSITIONED ON THE HIS. CS CATHETER AND THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER WERE CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). IMMEDIATELY AFTER CONNECTING THE CATHETERS TO THE PATIENT INTERFACE UNIT, BODY SURFACE (BS) AND INTRACARDIAC (IC) ECG SIGNALS WERE LOST ON THE EP RECORDING SYSTEM. NO ECG SIGNAL WAS AVAILABLE VIA THE ANESTHESIA MACHINE. THE CARTO 3 SYSTEM WAS STILL IN THE INITIALIZATION PHASE. NO PACING CHANNELS COULD BE SELECTED. SET-UP CONTINUED WITHOUT ECG SIGNALS AVAILABLE. CONNECTIONS BETWEEN THE EP RECORDING SYSTEM AND THE CARTO WERE CHECKED. CARTO, CATHETERS, AND CABLES WERE NOT SUSPECTED AS BEING THE SOURCE OF THE SIGNAL INTERFERENCE. THE ST. JUDE MEDICAL SL0 SHEATH WAS PLACED. CAPNOMETER MEASURED CARBON DIOXIDE AT ZERO, WHICH TRIGGERED THE ALERT FOR VENTRICULAR FIBRILLATION. AS A RESULT, THE EXTERNAL DEFIBRILLATOR WAS CONNECTED TO THE PATIENT, VF WAS IDENTIFIED, AND CARDIOVERSION WAS PERFORMED. ALTHOUGH CARDIOVERSION ATTEMPT # 1 WAS TRANSIENTLY SUCCESSFUL, THE PATIENT RESUMED VF. CARDIOVERSION ATTEMPT # 2 WAS SUCCESSFUL. CABLE WAS REPLACED AND THE ECG SIGNAL ISSUE REMAINED. CATHETERS WERE REMOVED FROM THE PATIENT. THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER AND CABLE WERE DISCONNECTED AND THE ECG SIGNALS (UNSPECIFIED) REAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419802 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S 17645963M 10846835009002

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R