BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 8529029 · Received April 18, 2019

    Report

    Report Number
    9681834-2019-00055
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 18, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE - UNKNOWN DUE TO THE LOT NUMBER BEING UNKNOWN. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K062858, K082644. THERE WAS NO RETURN OF THE ACTUAL SAMPLE TO BE EVALUATED. AS A REPRODUCTIVE TEST, A CURRENT MINI GUIDEWIRE SAMPLE WAS INSERTED INTO A METALLIC NEEDLE AND WITHDRAWN FROM IT. THE URETHANE COATING WAS SHEARED OFF THE MINI GUIDEWIRE SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE IFU STATES: "DO NOT USE A METAL CANNULA AS AN ENTRY NEEDLE. WITHDRAWING THE 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." BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS IT IS LIKELY THAT THE ACTUAL DEVICE WAS SUBJECTED TO A WITHDRAWAL MANIPULATION IN THE STATE WHERE ITS URETHANE OUTER LAYER HAD CONTACT WITH THE METALLIC NEEDLE USED IN COMBINATION WITH THE ACTUAL DEVICE. AS THE RESULT, THE URETHANE OUTER LAYER MAY HAVE GOT SHEARED OFF THE WIRE. HOWEVER, WITH NO RETURN OF THE ACTUAL SAMPLE TO BE EVALUATED, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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.HE ANCHOR HAS BEEN PROPERLY PLACED OR THE DEVICE WILL NOT FUNCTION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE ACTUAL DEVICE WAS USED AS A GUIDE WIRE FOR REPLACEMENT OF A PACEMAKER. WHEN IT WAS WITHDRAWN THROUGH A METAL NEEDLE, THE URETHANE OUTER LAYER OF THE ACTUAL SAMPLE GOT SHEARED AND REMAINED IN THE PATIENT'S BODY. THE FRAGMENT WAS SURGICALLY REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319845 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention