BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE,ST,MOD,S,HY,US 95-014

    MDR report key: 24589134 · Received March 13, 2026

    Report

    Report Number
    3006010712-2026-00007
    Event Type
    Death
    Date Received
    March 13, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 13, 2026
    Manufacturer
    LAKE REGIONMEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K160643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION COMPLETED AS PART OF THIS REPORT.

    Description of Event or Problem · 0

    ECN EVENT DESCRIPTION: THE TCAR WAS ORIGINALLY SCHEDULED TO BE DONE ON (B)(6) 2026 BUT WAS POSTPONED DUE TO THE PATIENT NEEDING CARDIAC CLEARANCE. THE CUTDOWN FOR THE PROCEDURE WAS UNEVENTFUL AND THE SHEATHS AND FLOW REVERSAL SYSTEM WERE PLACED WITHOUT ISSUE. A TCAR TIMEOUT WAS COMPLETED AND THE CAROTID CLAMPED. WHEN THE ENROUTE .014 WIRE WAS ADVANCED IT WAS NOT ADVANCING EASILY, ANOTHER IMAGE WAS TAKEN WHICH SHOWED A POSSIBLE DISSECTION. THE WIRE WAS REMOVED AND A NEW WIRE WAS OPENED. THE PHYSICIAN ADJUSTED THE TIP OF THE SHEATH AND THE NEW .014 ENROUTE WIRE ADVANCED WITHOUT ISSUE. AN ANGIOGRAM WAS TAKEN TO CONFIRM TRUE LUMEN WHICH SHOWED IT WAS AND THE PHYSICIAN CONTINUED TO BALLOON AND STENT WITHOUT ISSUE. AFTER GIVING TIME FOR WASHOUT ANOTHER ANGIOGRAM WAS PERFORMED IN TWO VIEW WHICH DID NOT SHOW A DISSECTION. THE WIRE & CLAMP WERE REMOVED WHICH CONTINUED TO SHOW NO DISSECTION. THE PHYSICIAN MADE THE DECISION TO REMOVE THE SHEATH AND INSPECT THE CAROTID. PER THE PHYSICIAN A WIRE PERFORATION TO THE POSTERIOR WALL WAS NOTED WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? FOR THE WIRE PERFORATION, A NEW WIRE WAS OPENED AND USED AND THE SHEATH TIP WAS ADJUSTED. WHAT IS THE NEXT COURSE OF ACTION?: N/A PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: DEATH IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: NO MEDICAL OR SURGICAL INTERVENTIONS: A CODE WAS CALLED PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: YES PATIENT DISCHARGED FROM HOSPITAL?: NO PATIENT OUTCOME: DEATH. EVENT DATE: 2026-2-10. AS REPORTED DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM. AS REPORTED PATIENT CODES: 9220: PERFORATION, VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558303 ENROUTE,ST,MOD,S,HY,US 95-014 ENROUTE 014 GUIDEWIRE DQX LAKE REGIONMEDICAL 901047-01 10015145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death