BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    MDR report key: 17940249 · Received October 13, 2023

    Report

    Report Number
    MW5146963
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCED A MEDICAL EMERGENCY/ARREST WHILE UNDERGOING A WATCHMAN DEVICE PLACEMENT PROCEDURE IN CATH LAB USING A VERSA CROSS CONNECT SHEATH. DURING THE PROCEDURE WHEN THE DILATOR ADVANCED TO THE MID LEFT ATRIUM, AN AIR BUBBLE ENGAGES THE RIGHT CORONARY ARTERY. CONCERN THAT VALVE ON PRODUCT MAY BE FAULTY/DEFECTIVE DESIGN IF ALLOWS AIR TO ENTER SYSTEM. PATIENT HAD ST CHANGES IN THE INFERIOR LEADS WITH TRANSIENT HEART BLOCK. PATIENT HAD TEMPORARY VENTRICULAR STANDSTILL REQUIRING EPINEPHRINE, ATROPINE AND 2 MINUTES OF CHEST COMPRESSIONS. ROSC(RETURN OF SPONTANEOUS CIRCULATION) ACHIEVED. TEMPORARY PACEMAKER PLACED AND PROCEDURE COMPLETED. PATIENT OVERALL PROGNOSIS IS POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313056 VERSACROSS CONNECT LAAC ACCESS SOLUTION DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening