BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER P030031/S053

    MDR report key: 7441406 · Received April 18, 2018

    Report

    Report Number
    2029046-2018-01445
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 20, 2018
    Report Date
    March 20, 2018
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009170
    Product Problem
    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT BWI PRODUCTS INCLUDE: STOCKERT J70 RF GENERATOR (US CATALOG # S7036, SERIAL # (B)(4)). (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH AN UNSPECIFIED THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE ABLATION WAS STOPPED BY AN ¿IMPEDANCE TO HIGH¿ ERROR MESSAGE. WHEN THE CATHETER WAS REMOVE FROM THE PATIENT¿S BODY, CLOTTING WAS FOUND STUCK TO THE TIP OF THE CATHETER. THE CLOTTING WAS WIPED OFF AND FLUSHING WAS CONDUCTED TO CONTINUE WITH THE PROCEDURE. IT WAS THEN FOUND THAT THE SETTING SELECTION ON THE GENERATOR WAS WRONG, A NON-IRRIGATION SETTING WAS SELECTED IN SPITE OF USING AN IRRIGATION CATHETER. THE PROCEDURE WAS COMPLETED NORMALLY. NO PATIENT CONSEQUENCES WERE REPORTED. THE ISSUE OF IMPEDANCE TO HIGH ERROR MESSAGE IS NOT A REPORTABLE EVENT. HOWEVER, THE CLOT FOUND ATTACHED TO THE TIP OF THE CATHETER IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283835 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER P030031/S053 CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. UNKNOWN 10846835009170

    Patients

    Seq Age Sex Outcome Treatment
    1