BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE

    MDR report key: 17705226 · Received September 7, 2023

    Report

    Report Number
    3012120746-2023-00007
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 31, 2023
    Report Date
    September 7, 2023
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    PMA / PMN Number
    K210685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMITTING THIS REPORT OR ANY RELATED INFORMATION DOES NOT IMPLY AN ACKNOWLEDGMENT THAT OUR EMPLOYEES OR OUR DEVICE ARE RESPONSIBLE FOR OR CONTRIBUTED TO THE REPORTED EVENT. PER FOLLOW UP, IT WAS OBSERVED THAT THE WIRES FOR THE SHORT SHEATHS (16FR AND 10FR) WERE INSERTED INTO THE RIGHT FEMORAL VEIN WITH THE GUIDANCE OF ULTRASOUND. ALL SHEATHS WERE PROPERLY ASPIRATED AND FLUSHED AS PER PROTOCOL. DURING THE PLACEMENT OF THE 16FR SHEATH, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE IN THE RIGHT FEMORAL VEIN, BUT ULTIMATELY, IT SUCCESSFULLY ADVANCED OVER THE WIRE PLACED IN THE RIGHT FEMORAL VEIN. THE SHEATH WAS ASPIRATED AND FLUSHED WITHOUT ANY ISSUES. THE PHYSICIAN'S PERSPECTIVE IS THAT THE TEAR IN THE VEIN WAS POTENTIALLY CAUSED BY THE ACQCROSS. HE EXPLAINED THAT WHEN THE ACQCROSS/FLEXCATH SYSTEM TURNED OUT OF THE 16FR SHORT SHEATH, ITS NATURAL CURVATURE AND STIFFNESS MAY HAVE CONTRIBUTED TO THE VEIN'S TEAR. THE DEVICE UNDERWENT EVALUATION, WHICH REVEALED NO SIGNS OF PHYSICAL DAMAGE OR DEFECTS. ATTEMPTS TO INSERT A NATIVE GUIDEWIRE WERE SUCCESSFUL AND MET NO RESISTANCE. NEEDLE EXTENSION AND RETRACTION FUNCTIONS OPERATED WITHOUT ANY ISSUES. AS THE DEVICE FUNCTIONED IN ACCORDANCE WITH ITS INTENDED DESIGN, THE ALLEGATIONS WERE UNABLE TO BE CONFIRMED OR REPLICATED. THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, PRIOR TO INTRODUCING THE ACQCROSS INTO THE PATIENT'S BODY, THE PHYSICIAN INSERTED A SUPER STIFF AMPLATZ WIRE INTO THE SUPERIOR VENA CAVA (SVC) UNDER FLUOROSCOPY GUIDANCE. DURING THE ATTEMPT TO INSERT THE ACQCROSS/FLEXCATH COMBINATION INTO A 16-FR SHEATH OVER THE PRE-POSITIONED WIRE WITHIN THE SVC, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE. NOTABLY, THERE WERE NO INDICATIONS OF ANY ANATOMICAL DIFFICULTIES, AND THE AMPLATZ WIRE SMOOTHLY PASSED THROUGH THE 16FR SHEATH INTO THE SVC, WHICH WAS CONFIRMED BY FLUOROSCOPY BEFORE ATTEMPTING TO ADVANCE THE ACQCROSS/FLEXCATH SYSTEM OVER IT. THE PHYSICIAN USED FLUOROSCOPY TO INVESTIGATE THE AREA OF RESISTANCE AND MADE AN ATTEMPT TO REPOSITION THE SYSTEM, BUT THESE EFFORTS WERE UNSUCCESSFUL. CONSEQUENTLY, HE DECIDED TO REMOVE BOTH THE SYSTEM AND THE WIRE, WHICH REVEALED A KINK IN THE WIRE. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 0.032 WIRE THAT CAME WITH THE ACQCROSS INTO THE SVC, BUT IT COULD NOT PROGRESS BEYOND THE POINT WHERE INITIAL RESISTANCE WAS ENCOUNTERED. AFTER REMOVING THE WIRE, A VENOGRAM OF THE RIGHT FEMORAL VEIN WAS PERFORMED, REVEALING A DISSECTION WITHIN THE RIGHT FEMORAL VEIN UNDER FLUOROSCOPY. THE 10-FR SHEATH WITH THE INTRACARDIAC ECHO, WHICH HAD BEEN PLACED BEFORE ATTEMPTING TO INSERT THE FLEXCATH/ACQCROSS FOR TRANSSEPTAL ACCESS, REMAINED IN POSITION WITHIN THE MAIN LUMEN OF THE VEIN, AS REPORTED BY THE PHYSICIAN. THE PHYSICIAN SOUGHT THE ASSISTANCE OF ANOTHER COLLEAGUE TO REMOVE THE 16-FR SHEATH FROM THE RIGHT FEMORAL VEIN AND APPLY PRESSURE WHILE HE GAINED ACCESS TO THE LEFT FEMORAL VEIN FOR TRANSSEPTAL ACCESS. THIS PROCEDURE WAS SUCCESSFUL, AND THE PATIENT'S STABILITY WAS MAINTAINED THROUGHOUT, WITH CONTINUOUS PRESSURE APPLIED IN THE RIGHT FEMORAL VEIN. GIVEN THE PATIENT'S STABLE HEMODYNAMICS, THE PHYSICIAN MADE THE DECISION TO PROCEED WITH THE CASE. TRANSSEPTAL ACCESS WAS ACHIEVED USING AN AGILIS AND BAYLIS NRG, AND THE CRYO ABLATION PROCEDURE WAS CARRIED OUT SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE AND DURING THE RECOVERY PERIOD AFTERWARD. THERE WAS NO NEED FOR ANY VASCULAR INTERVENTION, AND THE PATIENT WAS EXPECTED TO BE DISCHARGED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100385 ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE TRANSSEPTAL DILATOR/NEEDLE, PRODUCT CODE: DRE ACUTUS MEDICAL, INC. 900304 LN104545

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention 10F SHEATH| 16F SHEATH| AGILIS| AMPLATZ SUPER STIFF GUIDEWIRE| BAYLIS NRG| FLEXCATH ADVANCE STEERABLE SHEATH| INTRACARDIAC ECHO