BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 21982610 · Received May 8, 2025

    Report

    Report Number
    2124215-2025-29168
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 10, 2025
    Report Date
    June 12, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS RECEIVED FOR INVESTIGATION AT THE BOSTON SCIENTIFIC COMPLAINT INVESTIGATION SITE ON (B)(6) 2025, THE PRODUCT INVESTIGATION IS NOT YET COMPLETE AT THE TIME OF REPORTING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: RETURNED PRODUCTS CONSISTED OF THE WHOLE ENROUTE TC NEUROPROTECTION SYSTEM PLUS. DURING VISUAL ANALYSIS USING THE X-RAY, IT WAS VISUALIZED THAT THE PART OF THE GUIDEWIRE WAS BROKEN INSIDE THE ARTERIAL DILATOR. THE REMAINING COMPONENTS WERE VISUALLY ANALYZED, AND IT WAS REVEALED THAT THE ARTERIAL SHEATH HAD MISSING PAD PRINTING ON THE TIP AND THE NUMBERS "1" AND "2" WERE SCRAPPED OFF. VISUAL ANALYSIS OF THE GUIDEWIRE REVEALED MULTIPLE KINKS, AS WELL AS BUNCHING. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRE STRIPPED WITHIN THE DILATOR. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THERE WAS DIFFICULTY INSERTING THE ARTERIAL SHEATH OF THE NPS. ONCE THE SHEATH WAS IN PLACE, THERE WAS DIFFICULTY REMOVING THE 0.035 J-WIRE FROM THE SHEATH. THE INNER DILATOR AND 0.035 J-WIRE WERE REMOVED TOGETHER. ONCE REMOVED, IT WAS DISCOVERED THAT THE WIRE WAS STRIPPED. THE STRIPPED PORTION OF THE WIRE WAS SECURE WITHIN THE DILATOR. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE ANY DEVICE FRAGMENTS FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRE STRIPPED WITHIN THE DILATOR. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THERE WAS DIFFICULTY INSERTING THE ARTERIAL SHEATH OF THE NPS. ONCE THE SHEATH WAS IN PLACE, THERE WAS DIFFICULTY REMOVING THE 0.035 J-WIRE FROM THE SHEATH. THE INNER DILATOR AND 0.035 J-WIRE WERE REMOVED TOGETHER. ONCE REMOVED, IT WAS DISCOVERED THAT THE WIRE WAS STRIPPED. THE STRIPPED PORTION OF THE WIRE WAS SECURE WITHIN THE DILATOR. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE ANY DEVICE FRAGMENTS FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102083 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306232 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male