BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 14945841 · Received July 7, 2022

    Report

    Report Number
    9681834-2022-00122
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 7, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K062858, K082644. SINCE THE LOT NUMBER WAS UNKNOWN, HISTORY INSPECTIONS COULD NOT BE PERFORMED. SINCE THE LOT NUMBER WAS UNKNOWN, THE COMPLAINT FILE OF THE PRODUCT OF INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES COULD NOT BE SEARCHED. TERUMO MEDICAL PRODUCTS (TMP) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    THE ACTUAL PRODUCT WAS NOT RETURNED, INVESTIGATION COULD NOT BE PERFORMED. DUE TO UNKNOWN LOT NUMBER, HISTORY INSPECTIONS COULD NOT BE PERFORMED. THE ACTUAL PRODUCT WAS NOT RETURNED AND THE CONDITION OF IT COULD NOT BE CONFIRMED. THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PRIMARY PERCUTANEOUS CORONARY INTERVENTION (STEMI) PROCEDURE, RADIAL ACCESS WAS NOT ACHIEVED, AND IC ATTEMPTED FEMORAL ACCESS. THE PLASTIC ANGLED MINI GUIDEWIRE FROM THE GLIDESHEATH KIT INVOLVED WAS USED THROUGH AN EXTERNALLY SOURCED METALLIC PERCUTANEOUS ENTRY NEEDLE. THE COATING SHEARED OFF AT THE TIP AND EMBOLIZED TO THE PATIENT'S LUNGS. THE PATIENT REMAINED IN THE INTENSE CARE UNIT (ICU). THERE WAS NO ATTEMPT TO REMOVE THE EMBOLIZED COATING AS DECIDED BY CLINICIANS. THE PATIENT HAS A HIGH BODY MASS INDEX (BMI) CAUSING FEMORAL PUNCTURE TO BE PROBLEMATIC. NO MEDICAL INTERVENTION TO REMOVE COATING DONE PER CLINICIAN DECISION. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757120 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O