BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFACER® INSIDE-OUT®

    MDR report key: 23645279 · Received November 25, 2025

    Report

    Report Number
    1721504-2025-00624
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    QJH
    UDI-DI
    00884450762158
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO LOT NUMBER WAS PROVIDED; THUS, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND A SEARCH OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IN A LITERATURE ARTICLE (PUPPALA ET AL., 2025), CUSTOMER REPORTS " AN ADVERSE EVENT ASSOCIATED WITH THE SURFACER SYSTEM WAS IDENTIFIED IN A 2025 U.S. CASE REPORT. A PATIENT SUFFERED A CARDIAC ARREST DURING OR FOLLOWING SURFACER PROCEDURE. DETAILS OF RESUSCITATION AND PATIENT OUTCOME WERE NOT SPECIFIED IN THE ABSTRACT BUT WERE TEMPORALLY LINKED TO THE DEVICE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832696 SURFACER® INSIDE-OUT® REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS INC. 00884450762158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening