BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH SLENDER

    MDR report key: 10739289 · Received October 27, 2020

    Report

    Report Number
    9681834-2020-00227
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 27, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K142183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K926214. DEVICE MANUFACTURER DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. ADDRESS: (B)(6). THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD. IFU STATES: DO NOT PINCH THE PLASTIC CANNULA AND/OR THE SIDE TUBE WITH FORCEPS. IT WILL CAUSE SCRATCHES ON IT. ATTENTION SHOULD BE PAID NOT TO DAMAGE THE CANNULA WITH FORCEPS OR SHARP EDGED TOOLS. IT IS LIKELY THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE SKIN INCISION PERFORMED WHILE THE PLASTIC CANNULA WAS PLACED IN THE PATIENT. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED GLIDE-SHEATH SLENDER WAS USED DURING THE PROCEDURE. SKIN INCISION WAS PERFORMED WHILE A PLASTIC CANNULA WAS PLACED IN THE PATIENT. AS A RESULT, THE PLASTIC CANNULA WAS SEVERED, AND LEFT BEHIND IN THE PATIENT. IT WAS PLANNED THAT THE PATIENT WAS TRANSFERRED TO A NEARBY SURGERY, AND THE PLASTIC CANNULA WAS SURGICALLY REMOVED. HOWEVER, THE OUTCOME COULD NOT BE CONFIRMED. IT SEEMS THAT THERE WAS NO BLOOD LOSS BECAUSE THE PATIENT WAS TRANSFERRED WITH A WIRE LEFT IN THE BODY. CAG WAS PERFORMED APPROACHING FROM THE INGUINAL REGION. DUE TO FINDINGS OF AORTIC DISSECTION, THE PATIENT WAS TRANSFERRED TO A NEARBY SURGERY. IT IS DETERMINED THAT THE PLASTIC CANNULA LEFT BEHIND THE BODY WILL BE REMOVED AFTER THE AORTIC DISSECTION SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION RECEIVED ON 23OCT2020: THE DOCTOR CLARIFIED THAT AFTER THE WIRE WAS INSERTED, SKIN INCISION WAS PERFORMED CROSSWISE WHILE THE PLASTIC CANNULA OF THE PUNCTURE NEEDLE REMAINED IN THE VESSEL. AS A RESULT, THE PLASTIC CANNULA WAS SEVERED AND LEFT IN THE PATIENT. THE FRAGMENT WAS RETRIEVED SURGICALLY IN THE FACILITY WHERE THE PATIENT WAS TRANSFERRED, AND NO FURTHER PROBLEM OCCURRED. IT WAS 2 CM IN LENGTH AND DISCARDED AFTER THE RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205563 GLIDESHEATH SLENDER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1