BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 12853306 · Received November 22, 2021

    Report

    Report Number
    3005334138-2021-00670
    Event Type
    Injury
    Date Received
    November 22, 2021
    Report Date
    November 22, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, NO LOG FILES WERE RECEIVED. 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 INTERNATIONAL HEART JOURNAL ASSOCIATION- LEFT ATRIAL REVERSE REMODELING FOLLOWING THE MODIFIED BOX ISOLATION WITH CENTERLINE IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION BY YOSUKE MIWA,1 MD, ET AL: MAJOR COMPLICATIONS REQUIRING PERICARDIOCENTESIS WERE OBSERVED IN TWO PATIENTS: CEREBRAL EMBOLISM AND CARDIAC TAMPONADE. THE PATIENT WITH CEREBRAL EMBOLISM DID NOT RECEIVE CATHETER INTERVENTION BECAUSE OF THE THROMBOEMBOLISM OF THE DISTAL MIDDLE CEREBRAL ARTERY, UNDERWENT A 2-MONTH REHABILITATION, AND RECOVERED WITHOUT SUBSEQUENT DISABILITY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748977 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention