BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 23746390 · Received December 8, 2025

    Report

    Report Number
    3008452825-2025-00650
    Event Type
    Injury
    Date Received
    December 8, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ABBOTT 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

    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 CLINICAL AND APPLIED THROMBOSIS/HEMOSTASIS, VOL 31: 1-9, 2025; SAGE. "ACTIVATED CLOTTING TIME REQUIRES ADAPTATION ACROSS ALTERED MEASUREMENT DEVICES: DETERMINATION OF APPROPRIATE RANGE DURING ATRIAL. FIBRILLATION ABLATION"; HARUNA SAKANOUE, RN, HIROSUKE YAMAJI, MD. TWO SYSTEMS WERE COMPARED: ELECTROMAGNETIC DETECTION USING A ROTATING TUBE (EM SYSTEM; HEMOCHRON RESPONSE) AND PHOTO-OPTICAL DETECTION USING A CARTRIDGE IMMERSED IN BLOOD (PO SYSTEM; ACT CA-300TM). ACT TARGET RANGES SHOULD BE SYSTEM-SPECIFIC, AND DIRECT EXTRAPOLATION BETWEEN DEVICES IS NOT RECOMMENDED. ADJUSTMENT IS CLINICALLY NECESSARY WHEN SWITCHING SYSTEMS. CARDIAC TAMPONADE OCCURRED IN 4 OUT OF 2085 ABLATIONS OVER 5 YEARS, WITH ACT VALUES RANGING FROM 330 TO 391 S ON THE EM SYSTEM. BASED ON THESE FINDINGS, THE ESTIMATED OPTIMAL ACT RANGE FOR THE PO SYSTEM WAS ADJUSTED TO 225-300 S TO ALIGN WITH THE EM SYSTEM¿S RANGE OF 275-365 S. FOUR EVENTS OF CARDIAC TAMPONADE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2755898 TACTICATH¿ CONTACT FORCE 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 Life Threatening