BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM

    MDR report key: 8806960 · Received July 19, 2019

    Report

    Report Number
    9680001-2019-00096
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Report Date
    July 19, 2019
    Manufacturer
    VENUSA DE MEXICO S.A. DE C.V.
    Product Code
    OAE
    UDI-DI
    07640157990040
    PMA / PMN Number
    P130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER WAS RECEIVED FOR EVALUATION. FLUID WAS NOTED OUTSIDE OF THE IRRIGATION TUBING BUT WITHIN THE TYGON TUBING JUST DISTAL TO THE LUER HUB. FURTHER TESTING REVEALED A LEAK AT THE LUER/IRRIGATION TUBING JUNCTION DUE TO A GAP IN THE ADHESIVE BETWEEN THE IRRIGATION TUBE AND THE PROXIMAL TUBE INSIDE THE LUER LOCK, ALLOWING FLUID TO FLOW OUTSIDE OF THE IRRIGATION TUBING AND INTO THE PROXIMAL TUBING TOWARDS THE OPTICAL AND ELECTRICAL CONNECTORS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING AN IRRIGATION LEAK OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601986 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAE VENUSA DE MEXICO S.A. DE C.V. PN-004 075 6612567 07640157990040

    Patients

    Seq Age Sex Outcome Treatment
    1