BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFACER® INSIDE-OUT®

    MDR report key: 23645271 · Received November 25, 2025

    Report

    Report Number
    1721504-2025-00623
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    August 7, 2023
    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 (BOHLE ET AL., 2023), CUSTOMER REPORTS "A 71-YEAR-OLD FEMALE UNDERGOING SURFACER INSIDE-OUT CENTRAL VENOUS CATHETER PLACEMENT FOR THORACIC CENTRAL VENOUS OCCLUSION EXPERIENCED A NEAR-FATAL ARTERIAL INJURY. DURING ADVANCEMENT OF THE DEVICE, THE RIGHT INTERNAL MAMMARY ARTERY WAS INADVERTENTLY LACERATED, RESULTING IN MASSIVE BLEEDING AND CARDIOVASCULAR COLLAPSE. THE PATIENT REQUIRED TRANSFUSION, CHEST TUBE PLACEMENT, AND COIL EMBOLIZATION OF THE INJURED ARTERY. IMAGING REVIEW POST-PROCEDURE REVEALED THE TRAJECTORY OF THE DEVICE INTERSECTED THE ARTERY, INDICATING POTENTIAL FOR INJURY DUE TO ANATOMICAL VARIATION. THE EVENT RESULTED IN HEMOTHORAX AND PROLONGED HOSPITALIZATION, BUT THE PATIENT ULTIMATELY RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563672 SURFACER® INSIDE-OUT® REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS INC. 00884450762158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female