BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 7205096 · Received January 19, 2018

    Report

    Report Number
    9681834-2017-00270
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 19, 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

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K062858 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION AND WAS FOUND TO HAVE BEEN FRACTURED AT APPROXIMATELY 32MM FROM THE PROXIMAL END OF THE HUB. THE TOTAL LENGTH OF THIS PRODUCT IS SPECIFIED TO BE APPROXIMATELY 51MM IN TOTAL. FROM THIS, THE ACTUAL DEVICE WAS FOUND TO BE MISSING THE DISTAL SEGMENT APPROXIMATELY 19MM IN LENGTH. THE FRACTURED AND SEPARATED DISTAL SEGMENT WAS NOT RETURNED TO FOR EVALUATION. THE FRACTURE CROSS-SECTION WAS INSPECTED UNDER MAGNIFICATION AND ELECTRON MICROSCOPY. THE FRACTURE CROSS-SECTION HAD THE SMOOTH SURFACE, THERE WERE SOME ABRASIONS THAT HAD BEEN GENERATED ON THE SEGMENT ADJACENT TO THE FRACTURE, AND THE DISTAL END HAD BEEN STRETCHED. FROM THESE FINDINGS, IT IS LIKELY THAT THE ACTUAL DEVICE CAME INTO CONTACT WITH A RIGID OBJECT ON THE OUTER SURFACE AND IN THAT STATE WAS EXPOSED TO PULLING FORCE, RESULTING IN THE FRACTURE. THE OUTSIDE DIAMETER OF THE TUBE AND THE INSIDE DIAMETER OF THE HUB WERE CONFIRMED TO MEET THE SPECIFICATIONS. A REPRODUCTIVE TEST WAS PERFORMED ON CURRENT PLASTIC CANNULA SAMPLES. THE PLASTIC CANNULA SAMPLE WAS LET TO COME INTO CONTACT WITH A SCALPEL AND GIVEN A NICK WITH IT. SUBSEQUENTLY, THE DISTAL END WAS PINCHED WITH THE FINGERS AND PULLED UNTIL THE CANNULA GOT FRACTURED. THE PLASTIC CANNULA SAMPLE WAS LET TO COME INTO CONTACT WITH A METAL ENTRY NEEDLE AND GIVEN A PRICK WITH IT. SUBSEQUENTLY, THE DISTAL END WAS PINCHED WITH THE FINGERS AND PULLED UNTIL THE CANNULA GOT FRACTURED. THE DAMAGE DUPLICATED WAS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD FROM THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT THE ACTUAL DEVICE CAME INTO CONTACT WITH A HARD OBJECT AND GOT NICKED. ADDITIONALLY, IT WAS SUBJECTED TO A PULLING FORCE AND GOT FRACTURED. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: DO NOT PINCH THE PLASTIC CANNULA AND/OR THE SIDE TUBE WITH FORCEPS. IT MAY CAUSE SCRATCHES ON IT. ATTENTION SHOULD BE PAID NOT TO DAMAGE THE PLASTIC CANNULA WITH FORCEPS OR SHARP EDGED TOOLS. 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 A FRACTURE ON THE OUTER SHEATH. THE ACTUAL SAMPLE WAS USED ON THE PATIENT WITH HARD SKIN. WHEN A MINI GUIDE WIRE WAS INSERTED AND THE ACTUAL SAMPLE WAS WITHDRAWN, THE ACTUAL SAMPLE GOT FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFUL. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49684 GLIDESHEATH INTRODUCER CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 170908

    Patients

    Seq Age Sex Outcome Treatment
    1