BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    MDR report key: 9472887 · Received December 16, 2019

    Report

    Report Number
    1118880-2019-00350
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 15, 2019
    Report Date
    December 16, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K142183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO.1 TO UPDATE THE H3 SECTION AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 6FR GLIDESHEATH SLENDER SHEATH ALONG WITH A BARD DORADO BALLOON WAS RECEIVED FOR PRODUCT EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH SHAFT WAS FULLY PROLAPSED AND SEPARATED FROM THE HUB. THE CAULKING PIN WAS REMOVED FROM THE SHEATH AND THE INNER DIAMETER MEASURED AT 2.8321MM WHICH IS WITHIN MANUFACTURER SPECIFICATIONS. THE SHEATH INNER LUMEN WAS OBSERVED UNDER MICROSCOPE AND THERE WAS NO DAMAGE OR GROSS ANOMALIES. THE DORADO BALLOON WAS FULLY DEFLATED. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS 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 BALLOON WAS NOT PROPERLY DEFLATED DURING THE PROCESS OF WITHDRAWING THE BALLOON FROM THE PATIENT. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. 510(K): K152173;K102008. PATIENT WAS REPORTED TO BE (B)(6). THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DORADO BALLOON WOULD NOT PULL BACK THROUGH THE GLIDESHEATH SLENDER 6FR SHEATH. THE SHEATH INVERTED ON ITSELF. THE PATIENT WAS REPORTED TO BE OK; GOOD. THE PROCEDURE OUTCOME WAS GOOD. THEY DID NOT USE A CATHETER. THEY WENT BARE-BACK OVER WIRE IN THE CHILD PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 20 NOV 2019. THE PATIENT DID WELL AND WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268673 GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT) INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DORADO BALLOON