BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8622006 · Received May 17, 2019

    Report

    Report Number
    2029046-2019-03156
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 19, 2019
    Report Date
    April 19, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4/19/2019, BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND FOUND TRANSITION CRACKED OPEN WITH METAL EXPOSED. THE INVESTIGATIONAL ANALYSIS COMPLETED 5/29/2019. THE DEVICE WAS VISUALLY INSPECTED AND THE PEEK HOUSING TIP TRANSITION WAS FOUND CRACKED WITH METAL EXPOSED. DEFLECTION TESTING WAS PERFORMED AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED. THE CATHETER WAS OBSERVED UNDER THE X RAY MACHINE AND THE T BAR WAS FOUND SLID DOWN, CAUSING THE IMPROPER DEFLECTION CONDITION. ON 5/24/19, A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. AN INTERNAL CORRECTIVE ACTION WAS CREATED TO INVESTIGATE THE T BAR SLIPPAGE INSIDE THE TIP AND THE DAMAGE IN THE PEEK HOUSING TIP TRANSITION. MANUFACTURER REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURE REF NO: (B)(4).

    Description of Event or Problem · 1

    ON 4/19/2019, BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND FOUND TRANSITION CRACKED OPEN WITH METAL EXPOSED. UPON RECEIVING THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, INITIAL VISUAL INSPECTION IDENTIFIED THE TRANSITION CRACKED OPEN WITH METAL EXPOSED, REDDISH RESIDUE INSIDE, APPROXIMATELY 1.7 CM FROM THE DISTAL FROM END AND BUMPS ABOUT 2.1 CM FROM DISTAL END OF TIP DOME. THE OBSERVED CRACKED TRANSITION WITH EXPOSED METAL IS A MDR REPORTABLE. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS RETURNED LABELED WITH A COMPLAINT NUMBER FOR WHICH PRODUCT DETAILS, SUCH AS THE LOT NUMBER, DO NOT MATCH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION FOR THE WRONG PRODUCT RECEIVED, HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. A NEW COMPLAINT WAS CREATED TO INVESTIGATE AND REPORT THE MALFUNCTION FOUND ALTHOUGH NO SPECIFIC EVENT DETAILS ARE AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415232 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30156901L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1