BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4962021 · Received August 3, 2015

    Report

    Report Number
    9673241-2015-00497
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. BWI CONCOMITANT PRODUCTS USED: PRODUCT NAME: CARTO® 3 SYSTEM, US CATALOG #: FG540000, SERIAL #: (B)(4). PRODUCT NAME: SOUNDSTAR ECO 8F SIEMENS, US CATALOG #: 10439011, LOT #: E8002894. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE AND DURING THE PROCEDURE CARTO 3 SYSTEM CRASHED AND WENT BACK TO INITIAL SCREEN. THE CUSTOMER REOPENED AND RESUMED THE STUDY WITHOUT DATA BEING LOST. AT THE MOMENT THE SYSTEM RESTORED, THE SOUNDSTAR CATHETER DISPLAYED AN EEPROM ERROR. THE CLIENT WAS ADVICE TO CHANGE THE CATHETER FOR A NEW ONE. FURTHERMORE, ON (B)(6) 2015, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT AND IT WAS INFORMED THAT DURING ABLATION PHASE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT SUFFERED CARDIAC TAMPONADE. MOMENTS AFTER THE TAMPONADE WAS NOTED, THE WORKSTATION CRASHED AND A TRANSTHORACIC ECHO PROBE WAS USED TO MONITOR THE ONGOING EVENT. NEVERTHELESS, BECAUSE OF THE PATIENT POSITION AND STERILE DRAPES, THE TRANSTHORACIC IMAGE WAS SUBSTANDARD. ONCE THE SYSTEM REBOOTED, A SOUNDSTAR CATHETER WAS USED TO MONITOR THE TAMPONADE BUT AN EEPROM ERROR OCCURRED. THE PHYSICIAN REPLACED THE CATHETER TO AN 8F ACUNAV CATHETER CONNECTED DIRECTLY TO THE ULTRASOUND SYSTEM TO VISUALIZE THE HEART. PATIENT REQUIRED VASOPRESSIN ADMINISTRATION, PERICARDIOCENTESIS DRAINING A TOTAL OF 1.5 LITERS, EXTENDED HOSPITALIZATION UNDER INTENSIVE CARE UNIT AS WELL AS OPEN HEART SURGERY. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE ADDITIONAL INFORMATION WAS PROVIDED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SETTINGS DURING THE EVENT INCLUDE: POWER CONTROL MODE AT 25 WATTS, IRRIGATION FLOW SET TO 17 ML, ACTIVATED CLOTTING TIME BETWEEN 350 AND 400 SECONDS AS WELL AS AN AGILIS SHEATH WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505003 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-00-S UNKNOWN_D-1327-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R