BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE .014" GUIDEWIRE

    MDR report key: 22059732 · Received May 21, 2025

    Report

    Report Number
    3006010712-2025-00025
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 10, 2025
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    UDI-DI
    00811311020546
    PMA / PMN Number
    K160643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ECN EVENT DESCRIPTION: NULL PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: OTHER PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: DISSECTION IN LCCA IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN MEDICAL OR SURGICAL INTERVENTIONS: ADDITIONAL ENROUTE STENT USED TO COVER DISSECTION 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: OTHER PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: DISSECTION IN LCCA IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? UNKNOWN MEDICAL OR SURGICAL INTERVENTIONS: ADDITIONAL ENROUTE STENT USED TO COVER DISSECTION PATIENT OUTCOME: EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77617 ENROUTE .014" GUIDEWIRE ENROUTE .014" GUIDEWIRE DQX LAKE REGION MEDICAL 8846864 00811311020546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown