BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 7456380 · Received April 24, 2018

    Report

    Report Number
    9681834-2018-00067
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Report Date
    April 24, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K) NO. - K062858,K082644 H4: DEVICE MANUFACTURER DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. H6: DEVICE CODE - 3191 (NO CODE AVAILABLE) - BURR; ON DEVICE SURFACE THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTIONS FOUND THAT THE URETHANE OUTER LAYER HAD BEEN SHEARED IN THE DISTAL DIRECTION AT APPROXIMATELY 520MM FROM THE DISTAL END OF THE DEVICE. THE SHEAR CROSS-SECTION WAS FOUND TO HAVE A SMOOTH SURFACE. THE OUTSIDE SURFACE WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO BE WITHIN MANUFACTURER SPECIFICATIONS. FUNCTIONAL TESTING WAS CONDUCTED. A FACTORY-RETAINED MINI GUIDE WIRE WAS INSERTED INTO A METAL NEEDLE AND WITHDRAWN FROM IT. THE URETHANE OUTER LAYER WAS SHEARED. THE SURFACE OF THE SHEAR CROSS-SECTION WAS FOUND TO BE IN THE SMOOTH STATE. THE DAMAGE WAS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE WAS DUPLICATED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. THERE IS NO INDICATION THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION AND THE EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS WITHDRAWN THROUGH A METAL NEEDLE IN THE STATE OF ITS URETHANE OUTER LAYER HAVING CLOSE CONTRACT WITH THE EDGE OF THE METAL NEEDLE. THE IFU STATES: DO NOT USE A METAL CANNULA AS AN ENTRY NEEDLE. WITHDRAWING MINI GUIDE WIRE THROUGH A METAL CANNULA OR ADVANCING A METAL CANNULA OVER THE MINI GUIDE WIRE MAY RESULT IN SHEARING OF THE MINI GUIDE WIRE OR SCRAPING OF ITS PLASTIC COATING. THIS MAY LEAD TO DAMAGE TO THE BLOOD VESSEL OR THE SHEATH, AS WELL AS RELEASE OF FRAGMENTS FROM THE WIRE INTO THE BLOOD STREAM. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE AFTER BEING ONCE USED ON THE PATIENT, THE ACTUAL SAMPLE WAS FOUND TO HAVE A BURR ON THE SURFACE. THE ACTUAL SAMPLE WAS CHANGED OUT. THIS EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE OUTCOME IS UNKNOWN. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298322 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1