BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 24531302 · Received March 6, 2026

    Report

    Report Number
    2124215-2026-12522
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 6, 2026
    Report Date
    April 2, 2026
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, TZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT DOES NOT REPRESENT A NEW OR UNANTICIPATED RISK. THIS EVENT TYPE WAS ACCOUNTED FOR DURING THE PRODUCT RISK ANALYSIS TO SUPPORT AN ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "CAUSE NOT ESTABLISHED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO INSERT AND WAS SUBSEQUENTLY NOTED TO BE DAMAGED. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ARTERIAL SHEATH WAS INSERTED INTO THE LEFT COMMON CAROTID ARTERY AND DID NOT HAVE CONTACT WITH THE DISTAL CAROTID LESION. RESISTANCE WAS ENCOUNTERED, PROMPTING REMOVAL OF THE SHEATH. UPON INSPECTION, THE SHEATH TIP WAS OBSERVED TO BE FLARED AND DAMAGED. THERE WAS NO DISSECTION OR VESSEL TRAUMA NOTED. A SECOND NPS WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO INSERT AND WAS SUBSEQUENTLY NOTED TO BE DAMAGED. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ARTERIAL SHEATH WAS INSERTED INTO THE LEFT COMMON CAROTID ARTERY AND DID NOT HAVE CONTACT WITH THE DISTAL CAROTID LESION. RESISTANCE WAS ENCOUNTERED, PROMPTING REMOVAL OF THE SHEATH. UPON INSPECTION, THE SHEATH TIP WAS OBSERVED TO BE FLARED AND DAMAGED. THERE WAS NO DISSECTION OR VESSEL TRAUMA NOTED. A SECOND NPS WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593252 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306935 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown