BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH SLENDER NITINOL

    MDR report key: 10829888 · Received November 12, 2020

    Report

    Report Number
    1118880-2020-00280
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 12, 2020
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701009933
    PMA / PMN Number
    K142183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT HAS BEEN DEEMED NOT REPORTABLE BASED OFF THE INVESTIGATION OF THE ACTUAL DEVICE AND DETAILED REVIEW OF THE MANUFACTURING PROCESS..

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9 AND TO UPDATE SECTION H3.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY ORDERED 15-1060 HOWEVER, THE ACTUAL PRODUCT INSIDE OF THE BOX WAS 35-1060 AND WAS LABELED AS SUCH. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297521 GLIDESHEATH SLENDER NITINOL INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A YG17 00389701009933

    Patients

    Seq Age Sex Outcome Treatment
    1