BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURFACER®

    MDR report key: 25243535 · Received May 21, 2026

    Report

    Report Number
    1721504-2026-00080
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    QJH
    PMA / PMN Number
    DEN190038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED THE RADIO-OPAQUE TIP OF THE WORKSTATION SHEATH SEPARATED FROM THE MAIN SHAFT OF THE SHEATH WHEN IT WAS INSERTED INTO THE PATIENT WHILE STILL ON THE WIRE. THE DEVICE DETACHED IN THE SVC AND WAS RESOLVED WITH CONTRALATERAL ACCESS FOR A SNARE/RETRIEVAL BASKET. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214371 SURFACER® REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS INC. 34214970000

    Patients

    Seq Age Sex Outcome Treatment
    1