BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 19706632 · Received July 9, 2024

    Report

    Report Number
    3014526664-2024-00135
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 9, 2024
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTERIAL SHEATH WITH THE SHEATH STOPPER AND ARTERIAL DILATOR WAS RETURNED FOR INVESTIGATION HOWEVER, THE FLOW CONTROLLER WAS NOT RETURNED. UPON MICROSCOPIC INSPECTION, IT WAS OBSERVED THAT THE PAD PRINTED NUMBERS 2, AND 3 ON THE ARTERIAL SHEATH BODY WERE MISSING AND THE NUMBER 1 WAS PARTIALLY MISSING. THE PAD PRINTED NUMBERS 4 AND 5 WERE INTACT. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED UPON DEVICE INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE FAILED TO MEET SPECIFICATIONS BEFORE DISTRIBUTION. IT IS POSSIBLE THAT THE MISSING PAD-PRINTED MARKINGS COULD OCCUR FROM HANDLING OR INTERACTION WITH ANOTHER DEVICE. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF SIMILAR EVENTS. ALL REASONABLY AVAILABLE INFORMATION HAS BEEN PROVIDED BY THE COMPANY AT THE TIME OF SUBMISSION OF THIS REPORT. THE FIELDS THAT ARE BLANK ARE NOT AN OMISSION AND INDICATE THAT THE INFORMATION IS EITHER NOT APPLICABLE OR CURRENTLY UNAVAILABLE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PAD PRINTED NUMBERS 2 AND 3 ON THE ARTERIAL SHEATH WERE NOT VISIBLE WHEN ACCESSING THE COMMON CAROTID ARTERY (CCA) VIA TUNNELING. THE PAD PRINTED NUMBERS WERE NOT INSPECTED AT THE FACILITY PRIOR TO USE. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE ARTERIAL SHEATH OR ANATOMICAL FACTORS SUCH AS TORTUOSITY/CALCIUM THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE TCAR PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT. THIS REPORT IS BEING SUBMITTED AS A POSSIBLE MALFUNCTION WITH THE POTENTIAL FOR SERIOUS INJURY IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544850 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC. 305592 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other