BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREECLIMB 70 REPERFUSION SYSTEM

    MDR report key: 18664112 · Received February 7, 2024

    Report

    Report Number
    3016522967-2024-00003
    Event Type
    Death
    Date Received
    February 7, 2024
    Date of Event
    January 8, 2024
    Report Date
    February 7, 2024
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K223530N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FREECLIMB 70 WITH TENZING 7 WAS USED IN A PATIENT WITH ICAD AND AN OCCLUDED M2. DURING THE THIRD PASS THE PHYSICIAN FOUND THE TIP HAD DETATCHED AT THE PROXIMAL MARKER AROUND THE ICA TERMINUS INTO THE M1. PHYSICIAN ATTEMPTS TO REMOVE THE TIP WERE UNSUCCESSFUL. AS OF (B)(6) 2024 THE PATIENT WAS STILL ALIVE WITH A POST-PROCEDURE ASPECT SCORE OF 3. AT APPROXIMATELY (B)(6) 2024 THE PATIENT HAD MASSIVE INFARCT AND EDEMA AND EXPIRED SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438963 FREECLIMB 70 REPERFUSION SYSTEM PERCUTANEOUS CATHETER NRY ROUTE 92 MEDICAL, INC. 23110901

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death| L FULL LENGTH 070 REPERFUSION SYSTEM