BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8921661 · Received August 22, 2019

    Report

    Report Number
    2029046-2019-03563
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 2, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.  A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH LOT NUMBER 30233269M, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT IN THEIR SEVENTIES UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRIOR TO START THE PROCEDURE, A .6CM BASELINE PERICARDIAL EFFUSION WAS NOTICED ON INTRACARDIAC ULTRASOUND. THE PROCEDURE STARTED AND WAS COMPLETED. UPON PROCEDURE COMPLETION, THE EFFUSION WAS MEASURED, AND IT WAS NOTICED THAT INCREASED TO 1.2CM. CARDIAC TAMPONADE WAS CONFIRMED VIA TRANSESOPHAGEAL ECHO (TEE) AND INTRACARDIAC ECHO (ICE) CATHETER. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. EXTENDED HOSPITALIZATION (2 DAYS) WAS REQUIRED AS A RESULT OF THE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A COOK TRANSSEPTAL NEEDLE (CATALOG#: G02364). THE 8F AGILIS SHEATH WAS USED DURING THE PROCEDURE. THE PHYSICIAN BURNED ABOUT 45 SECONDS PER LESION ALONG THE CAVOTRICUSPID ISTHMUS (CTI) LINE AT 35 WATTS. THE POWER DID NOT TITRATE DURING THE ABLATION. THE PHYSICIAN BELIEVES THE TAMPONADE OCCURRED WHILE BURNING CTI LINE. THE TOTAL ABLATION TIME IS UNKNOWN. THE GENERATOR WAS USED IN POWER CONTROL MODE. THE SETTINGS USED INCLUDED: DEFAULT PRE/POST RF FLOW, 35WATTS, TEMPERATURE WITHIN NORMAL LIMITS, FLOW OF 15ML/MIN. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT. THE PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE, THE ACTIVATED CLOTTING TIME (ACT) WAS BETWEEN 300-350S WHILE IN THE LEFT ATRIUM - HEPARIN DRIP TURNED OFF WHEN WE MOVED TO THE RIGHT SIDE TO BEGIN CTI LINE ABLATION. THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED IN INFERIOR VENA CAVA (IVC). NO RE-ZEROING WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714860 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30233269M 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R