BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 24562368 · Received March 10, 2026

    Report

    Report Number
    3008452825-2026-00140
    Event Type
    Injury
    Date Received
    March 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 BATCH 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

    IN THE CHINESE LITERATURE REVIEW, ONE PUBLICATION STATES THAT: LITERATURE INFORMATION: ZHANG XUELIAN, AN BAIFU, CUI WENZHANG, ET AL. EFFECT OF HIGH-POWER RADIOFREQUENCY ABLATION GUIDED BY CONTACT FORCE MONITORING ON ATRIAL FIBRILLATION. CHINESE JOURNAL OF GERONTOLOGY, 2024, 44(01): 1¿4. SIXTY PATIENTS WITH ATRIAL FIBRILLATION WHO UNDERWENT LOW-POWER LONG-DURATION (LPLD) RADIOFREQUENCY ABLATION WERE INCLUDED AS THE CONTROL GROUP, AND 60 PATIENTS WHO UNDERWENT HIGH-POWER SHORT-DURATION (HPSD) ABLATION WERE INCLUDED AS THE STUDY GROUP. BOTH GROUPS USED LESION SIZE INDEX (LSI) TO GUIDE THE ENDPOINT OF EACH ABLATION LESION, WITH AN LSI TARGET OF 4.5¿5.5 FOR THE ANTERIOR WALL AND BOTTOM, AND 4.0¿4.5 FOR THE POSTERIOR WALL AND ROOF. THE BILATERAL SINGLE-SHOT PULMONARY VEIN ISOLATION RATE, PROCEDURE TIME, FLUOROSCOPY TIME, COMPLICATION RATE, AND 1-YEAR SUCCESS RATE WERE EVALUATED. AN EVENT OF STEAM POP FOLLOWED BY A SMALL PERICARDIAL EFFUSION WHICH WAS ASYMPTOMATIC AND DID NOT REQUIRE ANY INTERVENTION, AND TWO EVENTS OF INTRAOPERATIVE STROKE AFTER WHICH A CEREBRAL ANGIOGRAPHY REVEALED EMBOLIZATION OF A SMALL THROMBUS INTO A SEVERELY STENOTIC CEREBRAL ARTERY WITH FAVORABLE PROGNOSIS AFTER INTERVENTIONAL TREATMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616367 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