BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    MDR report key: 25132170 · Received May 9, 2026

    Report

    Report Number
    2124215-2026-25231
    Event Type
    Injury
    Date Received
    May 9, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OFK
    UDI-DI
    00685447019473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND PERFORATION. SURGICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT DURING A NON-VALVULAR AFIB/FALLS PROCEDURE A VERSACROSS RF WIRE WAS SELECTED FOR USE. DURING PROCEDURE, TRIVIAL EFFUSION NOTED PRE PROCEDURE. IT WAS ATTEMPTED TO CROSS THE ATRIAL SEPTUM WITH VERSACROSS CONNECT LAAC ACCESS SOLUTION, HOWEVER, IT WAS UNSUCCESSFUL. NRG USED TO CROSS ATRIAL SEPTUM SUCCESSFULLY. PERICARDIAL EFFUSION CHECK PERFORMED, INSIGNIFICANT PER MD AND PROCEEDED WITH CASE. TRUSTEER SHEATH AND PIGTAIL WERE INTRODUCED IN THE PATIENT. ICE REP ALERTED MD OF THE PROGRESSION OF THE EFFUSION. MD ASSESSED IT AS A SMALL EFFUSION AND PROCEEDED WITH CASE. POST LAA ANGIOGRAM, AN EFFUSION BECOMING LARGER WAS NOTICED SO THE MD WAS ALERTED. MD AGREED AND PROCEDURE WAS STOPPED AT THIS POINT. TRUSTEER SHEATH AND PIGTAIL WERE RETRACTED TO RIGHT SIDE OF HEART. ANESTHESIA ALERTED MD THAT PATIENT WAS HEMODYNAMICALLY UNSTABLE, BP 69/54. PHYSICIANS (EP & IC) DECIDED TO PERFORM PERICARDIOCENTESIS FOR CARDIAC TAMPONADE. PERICARDIOCENTESIS PERFORMED SUCCESSFULLY AND PATIENT INTUBATED IN CASE PATIENT NEEDED TO GO TO CV OR. THE PATIENT WAS TRANSFERRED TO THE EP LAB IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4871 VERSACROSS CONNECT LAAC ACCESS SOLUTION PERCUTANEOUS ATRIAL CATHETER KIT OFK BOSTON SCIENTIFIC CORPORATION VXAK0103 0038308562 00685447019473

    Patients

    Seq Age Sex Outcome Treatment
    1