BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMFLOW VECTOR

    MDR report key: 23287785 · Received October 15, 2025

    Report

    Report Number
    3023527320-2025-00004
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 12, 2025
    Report Date
    January 21, 2026
    Manufacturer
    LIMFLOW INC.
    Product Code
    MGZ
    UDI-DI
    00850041730134
    PMA / PMN Number
    K221902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VECTOR DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED. THE CATHETER AND THE TIP WERE RETURNED. NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED WHEN THE CATHETER AND TIP WERE INVESTIGATED. ADEQUATE ADHESIVE RESIDUE WAS OBSERVED IN THE CORRECT LOCATION ON THE TIP. THE ROOT CAUSE WAS NOT ESTABLISHED DURING THE INVESTIGATION; HOWEVER, THE FIELD FAILURE WAS MOST LIKELY DUE TO THE DEVICE NAVIGATING A CHALLENGING ANATOMY. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING A LIMFLOW TRANSCATHETER ARTERIALIZATION OF DEEP VEINS (TADV) PROCEDURE THE MEDICAL TEAM HAD DIFFICULTY DELIVERING THE VECTOR TO THE STARTING POINT. THE NOSE CONE OF THE VECTOR DEVICE BROKE OFF ON THE WIRE. THE PHYSICIAN WAS ABLE TO PUSH THE NOSE CONE OUT WITH A BALLOON THROUGH THE DISTAL VENOUS ACCESS. THERE WAS NO INJURY, AND THE NOSE CONE WAS SUCCESSFULLY REMOVED. A SECOND VECTOR DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792116 LIMFLOW VECTOR VALVULOTOME MGZ LIMFLOW INC. VT-US-23 00850041730134

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male