BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL LENGTH 070 REPERFUSION SYSTEM (FREECLIMB 70 REPERFUSION SYSTEM)

    MDR report key: 17822673 · Received September 27, 2023

    Report

    Report Number
    3016522967-2023-00002
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    July 28, 2023
    Report Date
    July 28, 2023
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    NRY
    UDI-DI
    00853799007541
    PMA / PMN Number
    K223530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TENZING 7 SEPARATED AT THE PROXIMAL MARKER INSIDE A PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE TENZING 7 WITH A SNARE AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096880 FULL LENGTH 070 REPERFUSION SYSTEM (FREECLIMB 70 REPERFUSION SYSTEM) PERCUTANEOUS CATHETER NRY ROUTE 92 MEDICAL, INC. 23051001 00853799007541

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention FREECLIMB 70 REPERFUSION SYSTEM