BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8341703 · Received February 14, 2019

    Report

    Report Number
    2029046-2019-02683
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    December 19, 2018
    Report Date
    December 28, 2018
    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

    INVESTIGATION SUMMARY : THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. AFTER FURTHER EVALUATION, IT WAS CONFIRMED THAT THE PEEK HOUSING TIP TRANSITION WAS CRACKED WITH METAL EXPOSED. THEN, DEFLECTION TEST WAS PERFORMED, AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED, AND THE CATHETER WAS OBSERVED UNDER THE X RAY MACHINE AND THE T BAR WAS FOUND SLID DOWN CAUSING THE IMPROPER DEFLECTION CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE T-BAR SLIPPAGE AND THE DAMAGE ON THE PEEK HOUSING TIP TRANSITION CANNOT BE DETERMINED, HOWEVER, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE ISSUE. MANUFACTURER'S REFERENCE # (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. PRODUCT ANALYSIS NOTED THAT THERE WAS A CRACK BETWEEN THE PEEK HOUSING AND TIP LUMEN WITH METAL EXPOSED. DURING THE PROCEDURE, THE CATHETER WOULD NOT DEFLECT ACCORDING TO SPECIFICATION. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT FOR EVALUATION ON JANUARY 17, 2019, AND IT WAS NOTED BASED ON THE INITIAL VISUAL INSPECTION, THAT THERE WAS A CRACK AND A BUMP BETWEEN THE PEEK HOUSING AND TIP LUMEN APPROXIMATELY 1.6 CM FROM THE DISTAL END TIP DOME WITH METAL EXPOSED. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF THE LAB FINDING OF THE CRACK BETWEEN THE PEEK HOUSING AND TIP LUMEN WITH METAL EXPOSED ON JANUARY 17, 2019 AND HAVE ASSESSED THIS LAB FINDING AS REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS JANUARY 17, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132223 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30048591M

    Patients

    Seq Age Sex Outcome Treatment
    1