BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    MDR report key: 22798357 · Received August 13, 2025

    Report

    Report Number
    2124215-2025-56604
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    UDI-DI
    00685447010524
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AT THE TIME OF THE SUBMISSION OF THIS REPORT, AS IT WAS NOT YET AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PATIENT HAD A PACEMAKER AND HISTORY OF VON WILLEBRAND DISEASE. THE TRANSEPTAL PUNCTURE (TSP) WAS COMPLETED IN AN INFERIOR/MID LOCATION ON THE FOSSA USING INTRACARDIAC ECHO (ICE) GUIDANCE. THE PHYSICIAN HAD CHALLENGES GETTING THE VERSACROSS WIRE PAST THE PACER LEADS AND HAD TO REDIRECT SEVERAL TIMES. AFTER GETTING ACROSS TO LEFT SIDE, THE 27MM WATCHMAN DELIVERY SYSTEM (WDS) WAS ADVANCED AND DEPLOYED. IT WAS NOTED THAT THE WDS WAS TOO SMALL AND HAD LOW COMPRESSION. THE WDS WAS REMOVED AND REPLACED WITH A LARGER 31MM WATCHMAN FLX PRO DEVICE. THE 31MM WDS MET POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA AND THE 31MM CLOSURE DEVICE RELEASED. A PERICARDIAL EFFUSION SWEEP WAS PERFORMED BEFORE THE PROCEDURE, SEVERAL TIMES DURING AND AFTER IMPLANT PROCEDURE WITH NO FINDINGS. IT WAS REPORTED THAT AFTER THE PATIENT WAS RETURNED TO POST-OP CARE AREA, THE PATIENT BLOOD PRESSURE WAS OBSERVED TO BE NOTABLY LOWER. THE ANESTHESIOLOGIST PERFORMED A LIMITED ECHO AND NO PERICARDIAL EFFUSION WAS SEEN. PER THE ANESTHESIOLOGIST, ALBUMIN AND FLUIDS WERE ADMINISTERED AND THE PATIENT VITALS TEMPORARILY RETURNED TO NORMAL. ABOUT 15-20 MINUTES LATER THE PATIENT BLOOD PRESSURE SOFTENED AND ANOTHER ECHO WAS PERFORMED. AT THIS TIME A MODERATE EFFUSION WAS SEEN ON IMAGING. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE ABOUT 400ML OF BLOOD WAS REMOVED TO TREAT THE EFFUSION. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) ONCE STABILIZED AND MONITORED OVERNIGHT. THE FOLLOWING MORNING, THE DRAIN WAS REMOVED FROM PATIENT'S CHEST. PER IMPLANTER, THE PATIENT WAS DOING WELL AND WAS DISCHARGED AS PLANNED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563610 VERSACROSS CONNECT LAAC ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC VXAK0007 0035221605 00685447010524

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H