BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA360 SURGICAL SYSTEM

    MDR report key: 25194681 · Received May 15, 2026

    Report

    Report Number
    1000125279-2026-00019
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 15, 2026
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    HMZ
    PMA / PMN Number
    K243503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE CLEFT AS A KNOWN COMPLICATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED, AS NO SPECIFIC SERIAL OR LOT INFORMATION WAS AVAILABLE. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VALIDATED PROCEDURES. AS THE DEVICE IS NOT AVAILABLE FOR RETURN, NO DEVICE MALFUNCTION COULD BE CONFIRMED.

    Description of Event or Problem · 0

    FIRST VIA USED, HE WAS ABLE TO ADVANCE THE CATHETER ABOUT 4 O CLOCK, AND THE PATIENT MOVED AND HE PULLED THE CATHETER. THERE WAS A LOT OF REFLUX AND HE THOUGHT THERE WAS A SMALL CLEFT. BUT HE WAS WELL AWARE THAT THE DEVICE DID NOT CAUSE OR WORSEN THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562455 VIA360 SURGICAL SYSTEM INFUSION PUMP HMZ NEW WORLD MEDICAL, INC. VIA360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention