BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3844469 · Received June 3, 2014

    Report

    Report Number
    9673241-2014-00213
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: LASSO NAV ECO CATHETER X2. CARTO PATCHES. COOLFLOW TUBING. TRANSEPTAL NEEDLE KIT. CARTO 3 SERIAL # (B)(4). STOCKERT: SERIAL # (B)(4). COOLFLOW PUMP: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION, PRIOR TO AN ADVERSE EVENT, THERE WERE CARTO 3 SYSTEM ISSUES: MAGNETIC FIELD DISTORTION (THAT ERROR WAS FIXED BY MOVING THE ARM OF FLUORO SYSTEM). ERROR MESSAGE NUMBER 371: MAPPING ELECTRODES NOT AVAILABLE. ALERTS: MESSAGE NUMBER 2601: END-EXPIRIUM DATA MISSING. ALERTS: MESSAGE NUMBER 88: ACCURATE FORCE READING OBSTRUCTION. AT THIS POINT, THE BELOW ITEMS WERE EXCHANGED: LASSO NAV ECO DONGLE. LASSO NAV ECO CABLE. LASSO NAV ECO CATHETER. NO RESULT WAS OBSERVED, THE ERROR MESSAGES WERE STILL POPPING UP. THE PHYSICIAN STARTED BY CREATING A LEFT ATRIAL GEOMETRY AND DOING A WIDE AREA CIRCUMFERENTIAL ABLATION TO ISOLATE THE LEFT AND RIGHT SIDED PULMONARY VEINS. AFTER THE VEINS WERE ISOLATED, THE ATRIAL FIBRILLATION TURNED INTO AN ATRIAL TACHYCARDIA. THE PHYSICIAN THEN PROCEEDED TO MAP THE LEFT AND RIGHT ATRIUMS TO DETERMINE WHERE THE TACHYCARDIA WAS ORIGINATING FROM. DURING THE CASE IT WAS IMPOSSIBLE TO TURN ACCURESP MODULE ON. THE PHYSICIAN PERFORMED THE CASE WITHOUT THE ACCURESP MODE ACTIVATED. AFTER APPROXIMATELY 6H OF PROCEDURE THE NURSE REPORTED THAT THE HEART PRESSURE WENT UP. IT WAS ACKNOWLEDGED THAT THE HEART TAMPONADE OCCURRED. THE PATIENT WAS STABLE TALK. NO INTERVENTION WAS PERFORMED. THE PATIENT IS BEING OBSERVED OVERNIGHT. THE PATIENT WILL NEED ANOTHER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323810 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-01-S UNK_D-1327-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L