BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11721154 · Received April 23, 2021

    Report

    Report Number
    2029046-2021-00659
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 22, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 03/19/2021. THE DEVICE EVALUATION WAS COMPLETED ON 04/08/2021. VISUAL ANALYSIS OF THE RETURNED CATHETER REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE OF THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. DEFLECTION TESTING WAS PERFORMED, IN ACCORDANCE WITH BIOSENSE WEBSTER INC, (BWI) PROCEDURES AND THE CATHETER FAILED. AFTERWARDS, THE CATHETER WAS DISSECTED AND IT WAS FOUND THAT THE T BARS SLID DOWN FROM ITS PLACE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30467717M NUMBER, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A HOLE ON THE PEBAX. INITIALLY, IT WAS REPORTED THAT THE DEFLECTION ON THE SMART TOUCH CATHETER BROKE PER THE PHYSICIAN. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. SINCE THE CATHETER IS UNABLE TO DEFLECT OR RELAX COMPLETELY, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 3/29/2021, A HOLE ON THE PEBAX AND REDDISH MATERIAL INSIDE IT. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 3/29/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616010 THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 30467717M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1