BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    MDR report key: 7286080 · Received February 21, 2018

    Report

    Report Number
    1118880-2018-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 23, 2018
    Report Date
    February 21, 2018
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701011363
    PMA / PMN Number
    K142183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED THE REPORTED DEVICE IS A KIT, THEREFORE TWO OTHER 510(K) NUMBERS ARE ASSOCIATED WITH THE DEVICE: K152173 AND K102008. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO.1 TO PROVIDE THE COMPLETED INVESTIGATION. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A PEDAL CASE USING A 4/5 GLIDESHEATH SLENDER AND A .035 METACROSS BALLOON. THE BALLOON WOULD NOT DEFLATE ENTIRELY AND INVERTED THE SHEATH. THERE WERE NO ISSUES, IT WAS A SUCCESSFUL PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON JANUARY 24, 2018. THE REPORTED BLOOD LOSS WAS LESS THAN 250CC, AND THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128877 GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT) INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A VH26 00389701011363

    Patients

    Seq Age Sex Outcome Treatment
    1