BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFACER® INSIDE-OUT®

    MDR report key: 23658628 · Received November 26, 2025

    Report

    Report Number
    1721504-2025-00679
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 26, 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 (BOHLE, 2023), CUSTOMER REPORTS " DURING SURFACER INSIDE-OUT CENTRAL VENOUS RECANALIZATION, PATIENT SUSTAINED RIGHT INTERNAL MAMMARY ARTERY LACERATION WITH MASSIVE HEMOTHORAX AND CARDIOVASCULAR COLLAPSE; MANAGED WITH TRANSFUSION, CHEST TUBE, AND ARTERIAL COIL EMBOLIZATION. DEVICE USE INTRA-PROCEDURE IMPLICATED; ADVANCED IMAGING SUGGESTED INJURY RISK ALONG PROJECTED DEVICE PATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568960 SURFACER® INSIDE-OUT® REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS INC. 00884450762158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R