BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4241996 · Received November 10, 2014

    Report

    Report Number
    9673241-2014-00470
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: C3 INTERFACE CABLE ¿ THERAPEUTIC, MODEL # D-1286-03-S, LOT # 15766921L; CARTO 3, MODEL# FG-5400-00M, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), MALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE SUFFERED CARDIAC TAMPONADE. THE IMPEDANCE WAS DISPLAYED 190-200 OHM WHEN THE SMART TOUCH CATHETER WAS INSERTED INTO THE CARDIAC CAVITY. THE IMPEDANCE WAS DISPLAYED AROUND 170 EVEN WHEN THE CATHETER WAS NOT IN CONTACT WITH A CARDIAC WALL. THE INDIFFERENT ELECTRODE WAS REATTACHED, THE CABLE FOR OF THE CATHETER CHANGED BUT THE ISSUE CONTINUED. FINALLY, THE CATHETER WAS CHANGED AND THE IMPEDANCE WAS SLIGHTLY DECREASED THEN THE ABLATION WITH 30W WAS STARTED. IN ADDITION, A BIG NOISE BEGAN AT THE CATHETER. THE NOISE WAS IMPROVED WHEN THE CABLE WAS CHANGED. JUST AFTER THE PROCEDURE, THE BLOOD PRESSURE DROPPED AND PERICARDIAL EFFUSIONS WAS CONFIRMED. CARDIAC DRAINAGE WAS CONDUCTED AND THEN THE PATIENT WAS STABLE. THE PHYSICIAN COMMENTED THAT CAUSE OF THE TAMPONADE WAS UNKNOWN, BUT THE EVENT MIGHT OCCUR DUE TO SEVERAL TIMES DC SHOCK OR TOUCHING TO THE CARDIAC MUSCLE BY THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722664 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-01-S 16102077M

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R