BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACQCROSS INTEGRATED NEEDLE/DILATOR

    MDR report key: 19347053 · Received May 17, 2024

    Report

    Report Number
    3012120746-2024-00009
    Event Type
    Death
    Date Received
    May 17, 2024
    Date of Event
    April 4, 2024
    Report Date
    June 14, 2024
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    UDI-DI
    00850027837154
    PMA / PMN Number
    K210685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FLEXCATH CROSS DEVICE WAS DISCARDED AND IS UNAVAILABLE FOR INVESTIGATION. PER DEVICE HISTORY RECORD REVIEW THERE WERE NO NOTED NON-CONFORMANCES. A ROOT CAUSE COULD NOT BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE IT IS MADE AVAILABLE.

    Additional Manufacturer Narrative · 0

    WHILE IT IS NOTED PER DEVICE INSTRUCTIONS FOR USE THE ACQCROSS QX NEEDLE LUMEN WILL ACCEPT GUIDEWIRE SIZES UP TO 0.032 INCHES (0.813MM) IN DIAMETER AN EXACT ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    DURING PUNCTURE OF THE LEFT FEMORAL VEIN, DURING THE INSERTION OF THE VASCULAR SHEATH (FLEXCATH ADV) WITH A NEEDLE FOR PUNCTURE OF THE ATRIAL SEPTUM, THE GUIDEWIRE WAS BLOCKED IN THE VASCULAR SHEATH, THE INFERIOR VENA CAVA WAS DAMAGED AND INTERNAL HEMORRHAGE OCCURRED. PATIENT OPERATED ON IN AN EMERGENCY MODE, DEATH AFTER THE PROCEDURE - HYPOVOLEMIC SHOCK. PER FOLLOW-UP FROM THE REPRESENTATIVE AT THE CASE ONLY THE ACQCROSS NEEDLE WAS FITTED, THE GUIDE WIRE WAS REPLACED WITH A HYDROPHILIC TERUMO- TO PUNCTURE THE SEPTUM. A BALLOON WAS NOT USED BECAUSE THE PROCEDURE WAS DISCONTINUED DUE TO SIGNS OF BLEEDING. THE AUTOPSY TOOK PLACE, THE OFFICIAL RESULT IS NOT YET AVAILABLE. ACCORDING TO THE ORAL REPORT OF THE PATHOMORPHOLOGIST, THE PATIENTS INFERIOR VENA CAVA WAS DAMAGED - AN OPENING OF ABOUT 2-3 MM, WHICH WAS SURGICALLY SUTURED. THE CAUSE OF DEATH WAS HYPOVOLEMIC SHOCK AS A RESULT OF RETROPERITONEAL BLEEDING.

    Description of Event or Problem · 0

    PER ADDITIONAL FOLLOW UP FROM THE PHYSICIAN THE RIGHT FEMORAL VEIN WAS SELECTED FOR ACCESS. A COMPLICATION OCCURRED WHEN MANEUVERING THE ORIGINAL GUIDEWIRE. THE PROWAX TERUMO GUIDEWIRE BECAME STUCK IN THE NEEDLE. THE PATIENT HAD NO DISCERNIBLE ANATOMICAL ANOMALIES. THE REPLACEMENT 0.035 IN. HYDROPHILIC TERUMO GUIDEWIRE WENT SMOOTHLY INTO THE SUPERIOR VENA CAVA AS VISUALIZED WITH FLUOROSCOPIC IMAGERY. THE NEEDLE WAS NOT REPLACED. THE SEPTUM PUNCTURE WAS NORMAL, BUT THE PROCEDURE WAS STOPPED DUE TO THE INCREASING HYPOTENSION AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453909 ACQCROSS INTEGRATED NEEDLE/DILATOR INTEGRATED NEEDLE/DILATOR DRE ACUTUS MEDICAL, INC. 900304 105357 00850027837154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death FLEXCATH SHEATH| TERUMO HYDROPHYLIC GLIDEWIRE