BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 11750686 · Received April 29, 2021

    Report

    Report Number
    2029046-2021-00690
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    January 3, 2021
    Report Date
    January 3, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 2/09/2021. THE DEVICE EVALUATION WAS COMPLETED ON 3/31/2021. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT A FISSURE WAS OBSERVED ON THE TIP, DUE TO T-BAR HAD SLID DOWN FROM ITS PLACE, ON THE SMART TOUCH CATHETER. DEFLECTION TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES AND THE CATHETER FAILED. AFTERWARDS, THE CATHETER WAS DISSECTED, AND IT WAS FOUND THAT THE T BAR HAD SLID DOWN FROM ITS PLACE, CAUSING A FISSURE ON THE TIP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30391599M 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. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. 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 (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A FISSURE ON THE TIP. INITIALLY, IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY . THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 3/31/2021 THAT A FISSURE WAS OBSERVED ON THE TIP. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 3/31/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646309 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30391599M

    Patients

    Seq Age Sex Outcome Treatment
    1