BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 21071636 · Received January 3, 2025

    Report

    Report Number
    3012120746-2025-00002
    Event Type
    Death
    Date Received
    January 3, 2025
    Date of Event
    September 3, 2023
    Report Date
    January 24, 2025
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K210685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING FOLLOW-UP INFORMATION TO COMPLETE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1, D2A, H6. ADDITIONAL DATA: B5. ROOT CAUSE COULD NOT BE DETERMINED. LOT NUMBER WAS NOT PROVIDED AND DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED. TEAR IS A POTENTIAL CLINICAL RISK ASSOCIATED WITH THE USE OF THE THE FLEXCATH CROSS DEVICE, WHICH IS THE SAME AS THE RISK OF A PROCEDURE PERFORMED WITH SIMILAR, COMPETITIVE DEVICES. THE REPORTED ADVERSE EVENT IS KNOWN INHERENT RISK OF THE DEVICE THAT IS DOCUMENTED IN THE LABELING. NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A ROUTINE CRYOBALLOON ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE WARD IN STABLE CONDITION, WITH NORMAL BLOOD PRESSURE AND HEART RATE, AND FEELING WELL. HOWEVER, SHORTLY THEREAFTER, THE PATIENT'S CONDITION DETERIORATED RAPIDLY, RESULTING IN A DROP IN BLOOD PRESSURE AND EVENTUAL ASYSTOLE. DESPITE RESUSCITATION EFFORTS, THE PATIENT PASSED AWAY. AN AUTOPSY REVEALED A SIGNIFICANT ACCUMULATION OF BLOOD IN THE ABDOMINAL CAVITY, CAUSED BY A VENOUS TEAR. ACCORDING TO THE PHYSICIAN, DURING THE INSERTION OF THE FLEXCATH ADVANCE SYSTEM (WITH THE FLEXCATH CROSS NEEDLE/DILATOR) INTO THE VENOUS SYSTEM, THE FLEXCATH CROSS NEEDLE/DILATOR SYSTEM DETACHED AND INADVERTENTLY RETRACTED FROM THE FLEXCATH, CAUSING THE VENOUS TEAR THAT ULTIMATELY LED TO THE PATIENT'S DEATH ON THE WARD. DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A ROUTINE CRYOBALLOON ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE WARD IN STABLE CONDITION, WITH NORMAL BLOOD PRESSURE AND HEART RATE, AND FEELING WELL. HOWEVER, SHORTLY THEREAFTER, THE PATIENT'S CONDITION DETERIORATED RAPIDLY, RESULTING IN A DROP IN BLOOD PRESSURE AND EVENTUAL ASYSTOLE. DESPITE RESUSCITATION EFFORTS, THE PATIENT PASSED AWAY. AN AUTOPSY REVEALED A SIGNIFICANT ACCUMULATION OF BLOOD IN THE ABDOMINAL CAVITY, CAUSED BY A VENOUS TEAR. ACCORDING TO THE PHYSICIAN, DURING THE INSERTION OF THE FLEXCATH ADVANCE SYSTEM (WITH THE FLEXCATH CROSS NEEDLE/DILATOR) INTO THE VENOUS SYSTEM, THE FLEXCATH CROSS NEEDLE/DILATOR SYSTEM DETACHED AND INADVERTENTLY RETRACTED FROM THE FLEXCATH, CAUSING THE VENOUS TEAR THAT ULTIMATELY LED TO THE PATIENT'S DEATH ON THE WARD. DEVICE WAS DISCARDED. PER FOLLOW-UP, WHEN PREPARED OUTSIDE OF THE PATIENT, THE 900304 WAS INSERTED INTO THE FLEXCATH AND A CLICK WAS HERD INDICATING SOLID CONNECTION. DURING INTRODUCTION OF THE SYSTEM INTO THE PATIENT THE 900304 DETACHED FROM THE FLEXCATH ("UN-CLICKED") AND RETRACTED, EXPOSING THE SHARP DISTAL EDGE OF THE FLEXCATH WHICH WAS IN THE PATIENT'S VEIN. THE PHYSICIAN BELIEVES THAT THE VEIN TEAR COMPLICATION OCCURRED AT THIS MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949467 FLEXCATH CROSS TRANSSEPTAL SOLUTION TRANSSEPTAL INTEGRATED DILATOR/NEEDLE DYB ACUTUS MEDICAL, INC. 900304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death