BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 23214197 · Received October 3, 2025

    Report

    Report Number
    1118880-2025-00141
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 3, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K152173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E3: OCCUPATION: INVENTORY CONSULTANT. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. ONE (1) 6 FR GLIDESHEATH DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE INCLUDES THE GUIDEWIRE. THE DEVICE WAS SUBJECTED TO VISUAL ANALYSIS. THE WIRE IS UNRAVELED FROM THE GUIDEWIRE CORE. ONE 6 FR GLIDESHEATH DEVICE WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE WAS AN UNCOILED GUIDEWIRE. THEREFORE, THE COMPLAINT CAN BE CONFIRMED FOR GUIDEWIRE MECHANICAL SEPARATION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THE GUIDEWIRE WAS WITHDRAWN THROUGH THE NEEDLE, WHICH SHEARED THE GUIDEWIRE AND LED TO THE OBSERVED UNCOILING. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW DETERMINED THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SHEATH COULD NOT BE ADVANCED INTO THE PATIENT'S BRACHIAL ARTERY AND WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE, IT BEGAN TO UNRAVEL. THERE WERE NO COMPONENTS LEFT BEHIND IN THE PATIENT, CONFIRMED BY POST-PROCEDURE IMAGING. THERE WERE NO ADVERSE OUTCOMES. THE TYPE OF PROCEDURE PERFORMED WAS A BRACHIAL IV ACCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 19AUG2025: THE ESTIMATED BLOOD LOSS COUNT WAS LESS THEN 250CC. THE PATIENT WAS STABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE EVENT OCCURRED WITHOUT PATIENT INJURY. THE SHEATH UNRAVELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226783 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION 15-1060 0001058180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown