BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE .014" GUIDEWIRE

    MDR report key: 22209945 · Received June 16, 2025

    Report

    Report Number
    3006010712-2025-00028
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 27, 2025
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K160643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION HAS BEEN COMPLETED AS PART OF THIS REPORT.

    Description of Event or Problem · 0

    ECN EVENT DESCRIPTION: NULL. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: DISSECTION. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: NO. MEDICAL OR SURGICAL INTERVENTIONS: PLACED ADDITIONAL STENT. PATIENT OUTCOME: EXPECTED TO FULLY RECOVER.

    Description of Event or Problem · 0

    ECN EVENT DESCRIPTION: NULL. PATIENT PRESENT AT TIME OF EVENT?: YES . PATIENT COMPLICATIONS: DISSECTION. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: NO. MEDICAL OR SURGICAL INTERVENTIONS: PLACED ADDITIONAL STENT . PATIENT OUTCOME: EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443415 ENROUTE .014" GUIDEWIRE ENROUTE .014" GUIDEWIRE DQX LAKE REGION MEDICAL 8846867

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown