BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 23075873 · Received September 17, 2025

    Report

    Report Number
    3008452825-2025-00457
    Event Type
    Death
    Date Received
    September 17, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HEART RHYTHM SOCIETY 2024; 21:1741¿1742. "CATHETER-RELATED AND CLINICAL COMPLICATIONS ASSOCIATED WITH CONTACT FORCE¿SENSING IRRIGATED ABLATION CATHETER"; JAKRIN KEWCHAROEN, MD TACTIFLEX¿ABLATION CATHETER, SENSOR ENABLED¿ (ABBOTT, MINNEAPOLIS, MN) IS AN OPEN-IRRIGATION RADIOFREQUENCY ABLATION CATHETER THAT MERGES CONTACT FORCE¿SENSING TECHNOLOGY IN A FLEXIBLE TIP DESIGN WITH REAL-TIME ASSESSMENT OF CONTACT FORCE VECTOR AND DEFLECTION INDICATOR ON THE CATHETER TIP. WITH CONTINUOUS TECHNOLOGIC ADVANCES IN CATHETER ABLATION, NEW DEVICE ISSUES MAY ARISE WITH SHORT- AND LONG-TERM IMPLICATIONS. TO BETTER UNDERSTAND THE WORLDWIDE EXPERIENCE, WE PERFORMED A RETROSPECTIVE CROSS-SECTIONAL ANALYSIS OF THE MAUDE (MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE) DATABASE. MAUDE IS AN UNRESTRICTED, DEIDENTIFIED DATABANK OF INDUSTRY (MANDATORY)¿ AND PATIENT/PHYSICIAN (VOLUNTARY)¿REPORTED ADVERSE EVENTS (AES) THAT OFFERS REAL-TIME ACCESS TO MEDICAL DEVICE FAILURE REPORTS. IN THIS CONTEXT, WE QUERIED ALL REPORTED TACTIFLEX AES FROM OCTOBER 1, 2022, TO OCTOBER 31, 2023, WHICH YIELDED 53 ENTRIES AFTER ELIMINATION OF DUPLICATES. TWO EVENTS OF CARDIAC PERFORATION OR PERICARDIAL EFFUSION WERE REPORTED WHICH REQUIRED PERICARDIOCENTESIS OR SURGICAL INTERVENTION AND RESULTED IN DEATH. ONE ESOPHAGEAL PERFORATION THAT RESULTED IN DEATH WAS ALSO REPORTED. NO DEVICE MALFUNCTION WAS ASSOCIATED WITH ANY CLINICAL ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648473 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death