BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22914007 · Received August 28, 2025

    Report

    Report Number
    2124215-2025-57589
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 4, 2025
    Report Date
    November 20, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6: FOLLOW-UP WAS ATTEMPTED, BUT THE INFORMATION FOR THE PATIENT-RELATED FIELDS IN SECTION A WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    A1-A6: FOLLOW-UP WAS ATTEMPTED, BUT THE INFORMATION FOR THE PATIENT-RELATED FIELDS IN SECTION A WAS NOT PROVIDED. MEDIA ANALYSIS: AN IMAGE WAS PROVIDED BY THE CUSTOMER THAT SHOWED THE DEVICE INSIDE THE PLASTIC HOUSING NEXT TO THE CARTON, WITHOUT A POUCH LABEL. IT WAS UNCLEAR WHETHER THE POUCH WAS REMOVED AT SOME POINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE WRAPPING WAS MISSING. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING PREPARATION FOR A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE NPS WAS NOTED TO BE ENCLOSED IN PLASTIC HOUSING BUT DID NOT HAVE THE STERILE WRAPPING. THE UNIT WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE WRAPPING WAS MISSING. A ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING PREPARATION FOR A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE NPS WAS NOTED TO BE ENCLOSED IN PLASTIC HOUSING BUT DID NOT HAVE THE STERILE WRAPPING. THE UNIT WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT NO STERILE PACKAGING APPEARED TO BE PRESENT; WHEN THE ORANGE OUTER BOX WAS OPENED AND THE NPS WAS REMOVED, NO STERILE POUCH OR PACKAGING WAS FOUND. IT ALSO COULD NOT BE CONFIRMED WHETHER THE TAMPER-PROOF SEAL WAS PRESENT ON THE OUTER DEVICE BOX PRIOR TO OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626271 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306242 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown