BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM

    MDR report key: 7608195 · Received June 16, 2018

    Report

    Report Number
    9680001-2018-00080
    Event Type
    Injury
    Date Received
    June 16, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 16, 2018
    Manufacturer
    VENUSA DE MEXICO S.A. DE C.V.
    Product Code
    OAE
    UDI-DI
    07640157990040
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, NO LOG FILES WERE RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION MAY HAVE BEEN PROCEDURE RELATED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION PROCEDURE OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), A PERICARDIAL EFFUSION WAS NOTED ON THE ANTERIOR ROOF OF THE LEFT ATRIUM NEAR THE RSPV. WHILE MANIPULATING THE ABLATION CATHETER ON THE ANTERIOR ROOF NEAR THE RSPV TO COMPLETE ABLATION, THE ABLATION CATHETER APPEARED OUTSIDE THE FUSED DIF IMAGE. FUSION OF THE DIF AROUND THIS POINT APPEARED TO BE ACCURATE. ALL THE PULMONARY VEINS WERE SUCCESSFULLY ISOLATED AND THE PROCEDURE WAS COMPLETED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION. A SUB-XYPHOID PUNCTURE AND INSERTION OF A PERICARDIAL DRAIN STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450656 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAE VENUSA DE MEXICO S.A. DE C.V. PN-004 075 6321494 07640157990040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention