BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ¿ INTRODUCER, UNKNOWN

    MDR report key: 23129915 · Received September 24, 2025

    Report

    Report Number
    3005334138-2025-00578
    Event Type
    Injury
    Date Received
    September 24, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6. A LITERATURE ARTICLE REPORTED EVENTS OF HEMATOMA, PSEUDOANEURYSM, AND TAMPONADE. 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.

    Additional Manufacturer Narrative · 0

    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 THE JOURNAL OF HEART RHYTHM SOCIETY IN AN ARTICLE TITLED, "DUAL-ATRIA ROTOR MODIFICATION: A COMPARATIVE ANALYSIS OF ROTOR MODIFICATION AND POSTERIOR WALL ISOLATION IN PATIENTS WITH PERSISTENT AND LONG-STANDING PERSISTENT ATRIAL FIBRILLATION" YOSHIFUMI OKANO, 2025 PUBLISHED BY ELSEVIER INC.(HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/). THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ROTOR MODIFICATION (RM) COMPARED TO POSTERIOR WALL ISOLATION (PWI) IN THE TREATMENT OF PERSISTENT AF. THE STUDY INCLUDED 50 PATIENTS IN THE RM GROUP (MEAN AGE: 67.0 6 8.7 YEARS; 76% WITH LONG-STANDING PERSISTENT AF) AND 50 PATIENTS IN THE PWI GROUP (MEAN AGE: 66.8 6 8.9 YEARS; 66%). IN THE RM GROUP, IN ADDITION TO CRYO BALLOON ISOLATION OF THE PULMONARY VEINS, ROTORS IN BOTH ATRIA WERE IDENTIFIED USING A PHASE MAPPING SYSTEM AND ABLATED AT LOW POWER. IN THE PWI GROUP, THE PULMONARY VEIN ANTRUM AND POSTERIOR WALL WERE ISOLATED TOGETHER USING A RADIOFREQUENCY CATHETER. THE PRIMARY END POINT WAS THE MAINTENANCE OF SINUS RHYTHM, DEFINED AS FREEDOM FROM ATRIAL TACHYCARDIA, AF, AND ATRIAL FLUTTER OVER A 36-MONTH POSTOPERATIVE FOLLOW-UP PERIOD. SURVIVAL CURVE ANALYSIS USING THE LOG-RANK TEST REVEALED A STATISTICALLY SIGNIFICANT DIFFERENCE (P , .001), DEMONSTRATING THE SUPERIORITY OF RM. RM IS SUGGESTED TO BE AS EFFECTIVE AS PWI OR MORE EFFECTIVE IN MAINTAINING SINUS RHYTHM IN PATIENTS WITH PERSISTENT AF. IN THE RM GROUP, THERE WAS 1 CASE OF FALSE FEMORAL ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734315 SWARTZ¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE