BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM

    MDR report key: 19940618 · Received August 7, 2024

    Report

    Report Number
    MW5158172
    Event Type
    Death
    Date Received
    August 7, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    QJH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I (ATTENDING VASCULAR SURGEON) WAS USING THE MERIT SURFACER DEVICE TO PLACE A TUNNELED CENTRAL LINE IN THIS PATIENT WITH AN SVC OCCLUSION. WE HAD PRE-PROCEDURE IMAGING WITH A CTV. THERE WERE TWO MERIT EMPLOYEES PRESENT, THE REGIONAL SALES REPRESENTATIVE AS WELL AS A CLINICAL EXPERT. THE DEVICE WAS DEPLOYED AS THEY DIRECTED (AND AS OUTLINED IN THE COMPANY'S DIRECTIONS FOR USE). THE PATIENT CODED IN THE OPERATING ROOM AND DIED. AUTOPSY IS PENDING, BUT I BELIEVE THERE WAS AN ARTERIAL GREAT VESSEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636141 SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Death