BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 18000214 · Received October 24, 2023

    Report

    Report Number
    3014526664-2023-00164
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 29, 2023
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 0.035" J-WIRE WAS INVESTIGATED. IT WAS OBSERVED THE ADHESIVE BOND SECTION WAS BROKEN AND ONE OF COIL RINGS WAS BENT AND WAS PROTRUDING BEYOND THE OUTER DIAMETER (OD) OF THE COIL. THE ROOT CAUSE OF THE DAMAGE IS UNKNOWN; HOWEVER, A POTENTIAL EXCESSIVE FORCE DURING USE COULD HAVE CAUSE THE BOND DAMAGE IN THIS ISOLATED UNIT. THERE IS NO INDICATION THE DEVICE DID NOT MEET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, INVESTIGATION OF THE DEVICE IS STILL IN PROCESS. 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. 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 ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE 0.035" J-TIP GUIDEWIRE BEHAVED UNCHARACTERISTICALLY WHEN ENTERING THE VESSEL. THE PHYSICIAN MANIPULATED THE WIRE TO BEND IN A J-SHAPE AND RESULTED IN DAMAGE OF THE WIRE WHICH CAUSED THE DISSECTION. AN UNPLANNED ADDITIONAL STENT WAS USED TO COVER THE DISSECTION. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691356 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL SR-200-NPS 305051 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention