BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 24536953 · Received March 6, 2026

    Report

    Report Number
    3008452825-2026-00117
    Event Type
    Injury
    Date Received
    March 6, 2026
    Report Date
    March 6, 2026
    Manufacturer
    ABBOTT MEDICAL,
    Product Code
    DRC
    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: CHENG JIFANG, ZHU XIA, JIANG SHENGBO, ET AL. NURSING CARE FOR PATIENTS UNDERGOING TRANSCATHETER MITRAL VALVE EDGE-TO-EDGE REPAIR USING THE DRAGONFLY¿ SYSTEM. JOURNAL OF NURSING SCIENCE, 2022, 37(24): 26¿29. TRANSCATHETER MITRAL VALVE EDGE-TO-EDGE REPAIR WAS PERFORMED IN 56 PATIENTS WITH MODERATE TO SEVERE MITRAL REGURGITATION. NURSES CONDUCTED COMPREHENSIVE PREOPERATIVE VISITS, ENSURED ADEQUATE PREPARATION OF SURGICAL INSTRUMENTS AND EQUIPMENT, AND ESTABLISHED EMERGENCY RESPONSE PLANS FOR VALVULAR INTERVENTIONAL PROCEDURES. DURING THE OPERATION, NURSES ASSISTED WITH PATIENT POSITIONING, CLOSELY MONITORED CLINICAL CONDITIONS, AND ACTIVELY CARRIED OUT PREVENTIVE NURSING MEASURES FOR POTENTIAL COMPLICATIONS. THE PROCEDURAL METHOD INVOLVED THE USE OF A ST. JUDE BRK¿ TRANSSEPTAL PUNCTURE NEEDLE. AN EVENT OF CARDIAC TAMPONADE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14067 TRANSSEPTAL NEEDLE, BRK SERIES Trocar DRC ABBOTT MEDICAL,

    Patients

    Seq Age Sex Outcome Treatment
    1