BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 13685001 · Received March 7, 2022

    Report

    Report Number
    3008988055-2022-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 18, 2022
    Manufacturer
    HERAEUS MEDICAL COMPONENTS
    Product Code
    EZB
    UDI-DI
    00827002448469
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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
    1166905 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS MHW- 035150 9007112132 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other