BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREECLIMB 54 REPERFUSION SYSTEM

    MDR report key: 21851260 · Received April 16, 2025

    Report

    Report Number
    3016522967-2025-00003
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 14, 2025
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K233329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. PRODUCT MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO QUALITY ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    A KINK OCCURED ON FREECLIMB 54 DURING THE A STROKE PROCEDURE. THE KINKED AREA WAS CLOSE TO BREAKING OFF. PROCEDURE WAS COMPLETED AND PHYSICIAN CONFIRMED NO PATIENT HARM AS THE CATHETER WAS FULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112529 FREECLIMB 54 REPERFUSION SYSTEM PERCUTANEOUS CATHETER NRY ROUTE 92 MEDICAL, INC. 25010208

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Other FREECLIMB 54 SYSTEM.