BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALINDROME

    MDR report key: 25277324 · Received May 26, 2026

    Report

    Report Number
    25277324
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MOZARC MEDICAL US LLC
    Product Code
    MSD
    UDI-DI
    10884521158023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INJURY OCCURRED, PULMONARY AIR EMBOLUS. DURING PLACEMENT OF TUNNELED CENTRAL VENOUS CATHETER, THE PEEL AWAY SHEATH VALVE FAILED AND A LARGE BOLUS OF AIR WAS SUCKED INTO THE SHEATH AND INTO THE HEART PROMPTING IMMEDIATE ADVANCED AIRWAY PROCEDURES, PATIENT REPOSITIONING, AND EMERGENT ANESTHESIA RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351045 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED MSD MOZARC MEDICAL US LLC 8888145039P 2430500182 10884521158023

    Patients

    Seq Age Sex Outcome Treatment
    1