BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVACROSS MICROCATHETER

    MDR report key: 9714168 · Received February 14, 2020

    Report

    Report Number
    3011816495-2020-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 13, 2020
    Manufacturer
    NITILOOP LTD
    Product Code
    DQY
    UDI-DI
    07290017436012
    PMA / PMN Number
    K172297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN USED THE DEVICE AND DEPLOYED IT THROUGH A VERY CALCIFIED LESION. WHILE THE TIP WAS SUBLUMENAL, THE USER APPLIED FORCES WITH NO INDICATION OF TIP ADVANCEMENT.

    Description of Event or Problem · 1

    TIP OF DEVICE BROKE OFF IN SUBINTIMAL SPACE OF TIBIAL ARTERY. LEFT IN PLACE. PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176992 NOVACROSS MICROCATHETER PERCUTANEOUS CATHETER DQY NITILOOP LTD NOVACROSS XTREME FP.000042 07290017436012

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other