BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6118190 · Received November 21, 2016

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    Report

    Report Number
    9673241-2016-00800
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    August 5, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    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. 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. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND A CLOT WAS STUCK TO THE TIP OF THE CATHETER DURING THE PROCEDURE. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE. THE GENERATOR WAS IN POWER CONTROL MODE. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS DURING THE PROCEDURE. IN ADDITION, THERE WERE NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. THE CATHETER WAS CHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT IS MDR REPORTABLE BECAUSE A CLOT HAS POOR ADHERENCE TO CATHETERS AND IT COULD BE A POTENTIAL SOURCE OF EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767041 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17451191M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1