BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMFLOW TRANSFORMING CLTI ARC

    MDR report key: 19647251 · Received June 28, 2024

    Report

    Report Number
    MW5156845
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 26, 2024
    Manufacturer
    LIMFLOW INC.
    Product Code
    PDU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE TIP OF THE CATHETER BROKE OFF INTO THE VESSEL IMPEDING ADVANCEMENT DURING A PROCEDURE AND TO RETRIEVE THE BROKEN TIP, SURGEONS HAD TO CONVERT TO OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684720 LIMFLOW TRANSFORMING CLTI ARC CATHETER FOR CROSSING TOTAL OCCLUSIONS PDU LIMFLOW INC. 82300571

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention