BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 20989472 · Received December 20, 2024

    Report

    Report Number
    3008452825-2024-00735
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE. AN EVENT OF GASTRIC HYPOMOTILITY WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF ARRHYTHMIA 00:1-10. JOHN WILEY & SONS AUSTRALIA, LTD ON BEHALF OF JAPANESE HEART RHYTHM SOCIETY. (2024) "FEASIBILITY AND EFFICACY OF 50 W ABLATION WITH THE TACTIFLEX CATHETER FOR THE INITIAL PULMONARY VEIN ISOLATION OF ATRIAL FIBRILLATION"; KAZUHISA MATSUMOTO MD, PHD. A PVI WAS PERFORMED IN 100 ATRIAL FIBRILLATION (AF) PATIENTS USING TACTIFLEX CATHETERS WITH A 50 W SETTING, 5-20 G CF, AND 15¿20 S ABLATION TIME. THE PRIMARY OUTCOMES INCLUDED A SUCCESSFUL PVI, THE INCIDENCE OF FIRST-PASS ISOLATIONS (FPIS), THE PRESENCE OF PV CONDUCTION GAPS, AND THE INCIDENCE OF COMPLICATIONS. ONE CASE OF GASTRIC HYPOMOTILITY WAS OBSERVED IN ONE CASE WHO UNDERWENT A BOX ISOLATION WAS REPORTED. IN A CASE IN WHICH GASTRIC HYPOMOTILITY OCCURRED, A PVI WAS PERFORMED WITH THE SAME PARAMETERS AS IN THE OTHER CASES, USING AN OUTPUT OF 50W AND CF OF 10¿20G, WITH ABLATION NEAR THE ESOPHAGUS LIMITED TO 7S. THAT PATIENT HAD PERSISTENT AF, AND BOTH THE ROOF LINE AND BOTTOM LINE WERE ABLATED UNDER THE SAME SETTINGS. IT WAS LIKELY THAT THE GASTRIC HYPOMOTILITY RESULTED FROM THE LINEAR ABLATION ACROSS THE ENTIRE POSTERIOR WALL OF THE LEFT ATRIUM, WHICH INVOLVED ABLATION ACROSS THE ESOPHAGEAL AREA. GASTRIC MOTILITY WAS MEDICALLY RESTORED THROUGH THE CESSATION OF ORAL INTAKE AND THE USE OF GASTROINTESTINAL PROKINETIC AGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061408 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown