BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6014201 · Received October 10, 2016

    Report

    Report Number
    9673241-2016-00686
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. CONCOMITANT PRODUCTS: SOUND STAR ECO CATHETER (MODEL# M-5723-17 SERIAL# (B)(4)). FIXED LASSO NAV ECO CATHETER (MODEL# D-1349-02-S LOT# 17446876L). THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER PMA # P030031/S053. (B)(4).

    Additional Manufacturer Narrative · 1

    ORIGINALLY, WE REPORTED THAT THE DEVICE IN THE 3500A INITIAL REPORT WAS NOT APPROVED BY THE FDA. HOWEVER, BIOSENSE WEBSTER INC. CONSIDERED IT A SIMILAR DEVICE AND WAS REPORTING THE EVENT. THIS SUPPLEMENTAL IS A CORRECTION AS THE PRODUCT WAS FDA APPROVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM DURING THE ABLATION FOR LEFT PULMONARY VEIN CARINA WITH USING THE SMARTTOUCH SF CATHETER. IN ADDITION, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN IDENTIFIED IT AS A CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED IN WHICH AN UNKNOWN AMOUNT OF FLUID WAS REMOVED AND THE PATIENT THEN RECOVERED. THE PATIENT HAS SINCE FULLY RECOVERED FROM THE EVENT. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY HOSPITALIZATION DUE TO THIS EVENT. THERE ARE NO KNOWN FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PHYSICIAN COMMENTED THAT CONTACT FORCE VALUE WAS 40G WITH RESPIRATORY TIMING DURING THE ABLATION WITH THE CATHETER. IT WAS NOTED THAT THE PHYSICIAN FELT THAT THE EVENT MIGHT HAVE CAUSED BY CONDUCTING TOO MUCH ABLATION. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THE GENERATOR WAS IN POWER CONTROL MODE. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665233 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-01-S 17400570L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R