BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 12005008 · Received June 15, 2021

    Report

    Report Number
    3014526664-2021-00082
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SILK ROAD MEDICAL INC
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. COMPLAINTS WILL CONTINUE TO BE REVIEWED AND MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED ON THE COMMON CAROTID ARTERY DURING INTRODUCTION OF THE ARTERIAL SHEATH OVER THE 0.035 J-TIP GUIDEWIRE. THE CONDITION OF THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894768 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC SR-200-NPS 301457 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention