BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 13306460 · Received January 20, 2022

    Report

    Report Number
    13306460
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 18, 2022
    Manufacturer
    COOK, INC.
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CIRCULATOR WAS INFORMED BY SURGEON THAT "A FRAGMENT OF THE HYDROPHILIC TIP FROM THE MOTION HYBRID WIRE GUIDE BROKE OFF AND WAS RETAINED IN THE PATIENT." THE SURGEON WAS ABLE TO VISUALIZE THE FRAGMENT WITH THE C-ARM THAT WAS CURRENTLY BEING USED DURING THE OPERATION. CIRCULATOR WAS INFORMED THAT THE FRAGMENT CANNOT BE REMOVED AT THIS TIME. CIRCULATOR NOTIFIED THE CHARGE NURSE AT THE FRONT DESK PER PROTOCOL AND COMPLETED SOS PER PROTOCOL. THE MOTION HYBRID WIRE GUIDE .035" REF MHW-035150/REF (B)(4), LOT 9007112132, EXPIRATION 01/27/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80326 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB COOK, INC. MHW-035150 9007112132

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA Female