BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 23263181 · Received October 10, 2025

    Report

    Report Number
    3008452825-2025-00506
    Event Type
    Death
    Date Received
    October 10, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    DURING A MITRACLIP IMPLANT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. INITIALLY, AFTER TRANSSEPTAL PUNCTURE A PERICARDIAL EFFUSION WAS NOT DETECTED. HOWEVER, WHEN PREPARING THE STEERABLE GUIDE CATHETER THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. A TRANSESOPHAGEAL ECHOCARDIOGRAM AND TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION AT THE LEFT UPPER PULMONARY VEIN. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO CARDIAC SURGERY. THE PATIENT EXPIRED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN DOES NOT ALLEGE THAT THE EVENT WAS DEVICE RELATED HOWEVER DOES ALLEGE THE EVENT WAS CAUSED BY TRANSSEPTAL PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936818 BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH TROCAR DRC ABBOTT MEDICAL G407209 10963406

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death| R| L