BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREECLIMB 70 REPERFUSION CATHETER WITH TENZING 7

    MDR report key: 24437726 · Received February 24, 2026

    Report

    Report Number
    3016522967-2026-00001
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 24, 2026
    Report Date
    February 23, 2026
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    NRY
    UDI-DI
    00853799007541
    PMA / PMN Number
    K223530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE RETURNED PRODUCTS SUBSTANTIATED THE REPORT.

    Description of Event or Problem · 0

    A 7F GUIDE SHEATH SEVERELY KINKED DURING USE MAKING WITHDRAWAL OF A FREECLIMB 70 CATHETER THROUGH THE GUIDE SHEATH DIFFICULT. THE KINKED SHEATH DAMAGED THE TIP OF THE FREECLIMB 70 CATHETER DURING WITHDRAWAL. A SUBSEQUENT CONTRAST INJECTION THROUGH THE GUIDE SHEATH EMBOLIZED THE DISTAL MARKER BAND FROM THE FREECLIMB 70 INTO THE A2 ARTERY. ONE ATTEMPT TO RETRIEVE THE MARKER BAND WITH THE FREECLIMB 54 AND A STENT RETRIEVER WAS UNSUCCESSFUL. THE MARKER BAND WAS NOT FLOW LIMITING SO IT WAS LEFT IN PLACE. DURING WITHDRAWAL INTO THE KINKED GUIDE SHEATH, THE DISTAL END OF THE FREECLIMB 54 WAS DAMAGED AND STRETCHED. PHYSICIAN ACKNOWLEDGED THAT CONSIDERABLE FORCE WAS REQUIRED TO RETRACT THE CATHETER(S) THROUGH THE KINKED SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498905 FREECLIMB 70 REPERFUSION CATHETER WITH TENZING 7 PERCUTANEOUS CATHETER NRY ROUTE 92 MEDICAL, INC. 25110606 00853799007541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 7F GUIDE SHEATH.| FREECLIMB 54.| FREECLIMB 70.| TREVO.