BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREECLIMB 70 REPERFUSION SYSTEM

    MDR report key: 21415588 · Received February 19, 2025

    Report

    Report Number
    3016522967-2025-00001
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 18, 2025
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K223530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND LOT INFORMATION WAS NOT PROVIDED THEREFORE PRODUCT COULD NOT BE INVESTIGATED.

    Description of Event or Problem · 0

    PATIENT WITH ACUTE ISCHEMIC STROKE IN RIGHT HEMISPHERE WAS SEDATED AND THE TENZING 7 DELIVERY CATHETER WAS ADVANCED INTO RIGHT INTERNAL CAROTID ARTERY. THE CATHETER WENT INTO POSTERIOR COMMUNICATING ARTERY AND A DISSECTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179949 FREECLIMB 70 REPERFUSION SYSTEM PERCUTANEOUS CATHETER NRY ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention FREECLIMB 70 SYSTEM