BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8483837 · Received April 4, 2019

    Report

    Report Number
    2029046-2019-02946
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    January 18, 2019
    Report Date
    January 18, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON APRIL 23, 2019, IT WAS NOTED THAT ¿D3. MANUFACTURER ADDRESS STREET LINE 1¿ ON THE 3500A INITIAL REPORT NEEDED CORRECTION. IT WAS INITIALLY SUBMITTED AS ¿31 TECHNOLOGY DRIVE¿. THE CORRECT ADDRESS IS ¿33 TECHNOLOGY DRIVE¿. THEREFORE, ¿D3. MANUFACTURER ADDRESS STREET LINE 1¿ HAS BEEN RE-POPULATED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS VISUALLY INSPECTED, AND THE PEEK HOUSING TIP TRANSITION WAS FOUND CRACKED WITH METAL EXPOSED AND POLYURETHANE (PU) MARGIN MISSING, ALSO A BUMP WAS OBSERVED IN THE TIP. 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 PEEK HOUSING DAMAGE CANNOT BE DETERMINED; HOWEVER, AN INTERNAL ACTION WAS CREATED TO INVESTIGATE BOTH ISSUES. (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® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND IT WAS REPORTED THAT THERE WAS A DEFLECTION ISSUE. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE DEFLECTION ISSUE WAS ASSESSED AS A NOT REPORTABLE EVENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON MARCH 6, 2019 AND IT WAS REPORTED THAT THE PEEK HOUSING WAS CRACKED OPEN WITH METAL EXPOSED AND POLYURETHANE (PU) MARGIN WAS MISSING WITH TRANSITION WITH THE TIP LUMEN. THE TIP LUMEN HAS BUMPS ABOUT 2.2 CM FROM THE DISTAL OF THE TIP DOME. THE ISSUE OF PEEK HOUSING CRACKED WITH EXPOSED PARTS WAS ASSESSED AS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275109 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30033475L

    Patients

    Seq Age Sex Outcome Treatment
    1