BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE 0.014'' GUIDEWIRE

    MDR report key: 15397258 · Received September 9, 2022

    Report

    Report Number
    3014526664-2022-00150
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    September 2, 2022
    Report Date
    September 9, 2022
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    UDI-DI
    00811311020546
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A PERFORATION WAS IDENTIFIED IN THE COMMON CAROTID ARTERY (CCA) AT THE END OF THE ENROUTE NEUROPROTECTION SYSTEM (NPS) ARTERIAL SHEATH WHILE USING THE 0.014" ENROUTE INTERVENTIONAL WIRE. THE CCA WAS REPAIRED WITH A SUTURE, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307853 ENROUTE 0.014'' GUIDEWIRE 0.014'' GUIDEWIRE DQX LAKE REGION MEDICAL SR-014-GW 5688825 00811311020546

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention