BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8022185 · Received October 30, 2018

    Report

    Report Number
    2029046-2018-02232
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 3, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.  IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 30077255L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: 1.DISTRIBUTED - STERILMED - REPROCESS SDSTR ECO 8F-90 GE, US CATALOG #: R10439236, LOT #: 2062861. 2. C3 EXTERNAL REFERENCE PATCH, US CATALOG #: CREFP6, LOT #: LL016711. 3. CARTO 3 SYSTEM, US CATALOG #: FG540000, LOT #: 29351. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, WHILE USING A REPROCESSED SOUNDSTAR ECO CATHETER, ERROR 6150 WAS DISPLAYED ON CARTO 3 SYSTEM. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. IT WAS ALSO REPORTED THAT 1006 BACK PATCH SENSOR ERROR WAS DISPLAYED. THE PATIENT INTERFACE UNIT (PIU) AND WORKSTATION WERE REBOOTED WITHOUT RESOLUTION. THE BACK-PATCH SENSOR CABLE WAS SWITCHED WITH THE CHEST PATCH CABLE AND THE ERROR FOLLOWED. SWITCHED THE 3 CARTO PATCHES ON THE BACK AND THE ISSUE RESOLVED. AT THE END OF THE CASE, A CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 700 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION, PATIENT¿S OUTCOME OR PHYSICIAN CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE ERROR MESSAGES WERE ASSESSED AS NOT REPORTABLE. THE RISK TO THE PATIENT WAS REMOTE. 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 WAS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862310 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30077255L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1