BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F

    MDR report key: 18784167 · Received February 26, 2024

    Report

    Report Number
    3008452825-2024-00083
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 30, 2024
    Report Date
    May 23, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027641
    PMA / PMN Number
    P130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5, H2, H6.

    Additional Manufacturer Narrative · 0

    ONE BI-DIRECTIONAL, CURVE D-F, TACTICATH SENSOR ENABLED CONTACT FORCE ABLATION CATHETER WAS RECEIVED FOR EVALUATION. ALTHOUGH FLUID WAS OBSERVED TO FLOW OUT OF ALL IRRIGATION HOLES, THE CATHETER DISPLAYED ASYMMETRIC FLOW WHILE PRIMING; HOWEVER, FURTHER INVESTIGATION DETERMINED THIS BEHAVIOR WAS ONLY PRESENT DURING PRIMING FLOW RATES AND NOT DURING THERAPEUTIC FLOW RATES. FLUID WITHIN THE IRRIGATION LUMEN BECOMES TURBULENT DURING PRIMING WHICH LEADS TO THE OBSERVED ASYMMETRIC FLOW FROM THE IRRIGATION PORTS. FLOW IS NON-TURBULENT AT NORMAL THERAPEUTIC RANGES AND FLUID EXITS THE TIP IN A BALANCED PATTERN. THE DEVICE MET SPECIFICATIONS DURING TEMPERATURE TESTING, OCCLUSION TESTING, AND LEAK TESTING. ELECTRODE 1 AND THE TIP THERMOCOUPLE MET SPECIFICATIONS DURING ELECTRICAL TESTING WITH NO OPEN OR SHORT CIRCUITS DETECTED. IN ADDITION, NO ANOMALIES WERE NOTED DURING MICROSCOPIC INSPECTION OF THE DISTAL TIP. THE DEVICE HISTORY RECORDS FOR EACH POSSIBLE BATCH NUMBER (8995844 OR 9214088) WERE REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED HIGH TEMPERATURES AND CHAR REMAINS UNKNOWN.

    Description of Event or Problem · 0

    CHANGE TO A CODE, E CODE, AND UPDATED EVENT DESCRIPTION. DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT IRRIGATION WAS ONLY FLOWING THROUGH FOUR OF THE CATHETER'S SIX IRRIGATION PORTS, AND THAT THERE WERE HIGH TEMPERATURES DURING ABLATION. AN ESCHAR WAS ALSO OBSERVED ON THE CATHETER TIP WHEN ABLATING AT THE BOTTOM OF THE RIGHT PULMONARY VEIN. THE CATHETER AND THE ESCHAR WERE REMOVED FROM THE PATIENT, THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, IT WAS NOTED THAT IRRIGATION WAS ONLY FLOWING THROUGH FOUR OF THE CATHETER'S SIX IRRIGATION PORTS, AND THAT THERE WERE HIGH TEMPERATURES DURING ABLATION. A LARGE SCAB-LIKE MATERIAL WAS ALSO OBSERVED WHEN ABLATING AT THE BOTTOM OF THE RIGHT PULMONARY VEIN. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    THIS REPORT INCLUDES UPDATED DEVICE LOT# AND EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629923 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL A-TCSE-DF 8995844 05415067027641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown