BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 17610970 · Received August 24, 2023

    Report

    Report Number
    2124215-2023-45578
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    June 29, 2022
    Report Date
    August 24, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K183655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC PERFORATION AND WAS COUGHING UP BLOOD. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, THE PATIENTS RIGHT ATRIUM (RA) WAS VERY LARGE AND THE PHYSICIAN HAD A VERY HARD TIME CROSSING THE SEPTUM. MULTIPLE PRODUCTS WERE USED, AND EVENTUALLY THEY DECIDED TO USE A STEERABLE SHEATH ALONG WITH A VERSACROSS ACCESS SOLUTION SYSTEM. THE PHYSICIAN WAS ABLE TO SEE ON THE SUPERIOR ASPECT OF THE SEPTUM, BUT THEY WERE NOT ABLE TO VISUALIZE ON THE SHORT-AXIS (SAX) VIEW. THE IMAGER STATED MULTIPLE TIMES THAT SHE FELT THEY WERE VERY POSTERIOR. DESPITE THIS POSTERIOR POSITION THE PHYSICIAN DECIDED TO CONTINUE WITH RADIOFREQUENCY (RF) APPLICATION. THE RF BUTTON WAS PRESSED FOUR TOTAL TIMES BEFORE THEY FINALLY WERE ABLE TO GET TO THE LEFT SIDE. AFTER THE LONG PROCESS TO ACHIEVE TRANSSEPTAL (TSP), THE WATCHMAN PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE CASE WAS FINISHED. WHILE IN RECOVERY, THE PATIENT BEGAN TO COUGH UP BLOOD. SHE WAS REINTEGRATED AND A BRONCHOSCOPE WAS PLACED TO EVALUATE THE LUNGS. THE PATIENT WAS FOUND TO HAVE A SMALL RIGHT PULMONARY VEIN (PV) PERFORATION WHICH CAUSED HER BLEEDING AND MOMENTOUS BLOOD BEING COUGHED UP. NO OTHER INTERVENTIONS WERE DONE. HOWEVER, WHEN REVIEWING WITH THE PHYSICIAN, IT WAS THOUGHT THAT AFTER TSP CROSSING THE WIRE SLIPPED INTO THE RIGHT PULMONARY VEIN WHICH CAUSED TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307655 VERSACROSS ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention