BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGEREYE

    MDR report key: 14409562 · Received May 13, 2022

    Report

    Report Number
    MW5109728
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Report Date
    May 12, 2022
    Manufacturer
    AVINGER, INC.
    Product Code
    NQQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING LOWER EXTREMITY PERCUTANEOUS INTERVENTION, CATHETER ATTEMPTED TO CROSS A SEVERELY CALCIFIED AREA IN THE RIGHT MEDIAL CIRCUMFLEX FEMORAL ARTERY. DURING THE PLACEMENT OF CATHETER, THE DISTAL TIP OF THE TIGEREYE CATHETER BECAME DISLODGED IN THE VESSEL. THE TIP REMAINS IN THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268550 TIGEREYE SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ AVINGER, INC. 210621001

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Other