BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 8407323 · Received March 11, 2019

    Report

    Report Number
    9681834-2019-00030
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 11, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K062858, K082644 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE DISTAL SECTION HAD BEEN FRACTURED. THE ACTUAL DEVICE WAS COMPARED WITH THE NORMAL PRODUCT OF THIS PRODUCT CODE FOR THE TOTAL LENGTH AND FOUND TO HAVE BEEN SHORTER THAN THE NORMAL PRODUCT BY APPROXIMATELY 25MM, INDICATING THAT THE DISTAL SECTION APPROXIMATELY 25MM IN LENGTH IS MISSING. ELECTRON MICROSCOPIC INSPECTIONS OF THE FRACTURE END OBTAINED THE FINDINGS AS FOLLOWS. URETHANE OUTER LAYER HAD THE TRACE WHICH IMPLIED THAT IT HAD BEEN PINCHED FROM BOTH SIDES. CORE WIRE HAD THE CONFIGURATION WHICH IMPLIED THAT IT HAD BEEN PINCHED FROM BOTH SIDES. REPRODUCTIVE TESTING WAS PERFORMED ON A MINI GUIDEWIRE TEST SAMPLE. IT WAS PINCHED WITH A PAIR OF PLIERS UNTIL IT WAS CUT. ELECTRON MICROSCOPIC INSPECTION OF THE CUT END FOUND IT WAS IN THE STATE WHICH WAS SIMILAR TO THAT OF THE FRACTURE END OF THE ACTUAL DEVICE. THE URETHANE OUTER LAYER HAD THE TRACE WHICH IMPLIED THAT IT HAD BEEN PINCHED FROM BOTH SIDES. THE CORE WIRE HAD THE CONFIGURATION WHICH IMPLIED THAT IT HAD BEEN PINCHED FROM BOTH SIDES A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE IFU STATES "DO NOT USE IF THE UNIT PACKAGE OR THE PRODUCT HAS BEEN DAMAGED OR SOILED." THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS PINCHED FROM BOTH SIDE WITH A HARD OBJECT AT APPROXIMATELY 25MM FROM THE DISTAL END OF THE DEVICE. HOWEVER, 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 UPON UNPACKING THE RADIFOCUS INTRODUCER II H SHORT-ANGLED MINI GUIDEWIRE, THE USER FELT IT DID NOT HAVE THE PROPER SHAPE ON THE DISTAL SECTION. IT APPEARED THAT THE DISTAL SECTION HAD BEEN CUT. THE ACTUAL SAMPLE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201817 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 180920

    Patients

    Seq Age Sex Outcome Treatment
    1