BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY ABLATION CATHETER-UNKNOWN

    MDR report key: 25280499 · Received May 26, 2026

    Report

    Report Number
    3008452825-2026-00297
    Event Type
    Injury
    Date Received
    May 26, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 KOREAN CIRCULATION JOURNAL, 2026 APR;56(4):329-340. "ASSOCIATION OF HYPOTHYROIDISM WITH ATRIAL SUBSTRATE BURDEN AND RECURRENCE FOLLOWING CATHETER ABLATION OF ATRIAL FIBRILLATION"; JOSE ANTONIO L. BAUTISTA, MD WE RETROSPECTIVELY REVIEWED PATIENTS WHO UNDERWENT AF ABLATION FROM 2015 TO 2019. BASELINE CLINICAL, ECHOCARDIOGRAPHIC, AND ELECTROPHYSIOLOGIC PARAMETERS WERE COMPARED BETWEEN HYPOTHYROID AND EUTHYROID GROUPS. PULMONARY VEIN (PV) AND NON-PV (NPV) TRIGGERS, AS WELL AS AF DRIVERS, WERE ANALYZED. MULTIVARIATE COX REGRESSION IDENTIFIED PREDICTORS OF AF RECURRENCE. ADVERSE EVENTS OF PERICARDIAL EFFUSION WITH TAMPONADE REQUIRING A PERICARDIOCENTESIS AND AN EVENT OF CORONARY ARTERY SPASM OF THE MIDDLE RIGHT CORONARY ARTERY DURING THE PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407828 FLEXABILITY ABLATION CATHETER-UNKNOWN catheter, percutaneous, cardiac ablation, for treatment of atrial flutter OAD ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L