BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCT CATHETER

    MDR report key: 18150792 · Received November 15, 2023

    Report

    Report Number
    MW5148195
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    November 9, 2023
    Report Date
    November 13, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE OCT(OPTICAL COHERENCE TOMOGRAPHY) CATHETER GOT STUCK ON THE INTERVENTIONAL WIRE NEAR THE END OF THE CASE AND BOTH THE CATHETER AND THE WIRE HAD TO BE REMOVED PREMATURELY. THE OCT DEVICE DID NOT ENTER THE PATIENT. THE EVENT DESCRIPTION WAS NOT CORRECT PER DR (B)(6). SHE NOTICED THAT IT DID NOT LOAD ONTO THE WIRE AND ASKED FOR A NEW OCT. NO HARM OR PATIENT CONTACT FOR THIS DEVICE. VENDER IS AWARE. ABBOTT DRAGONFLY OPSTAR REF 1014651, LOT 9163070 EXP 08/02/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906375 OCT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO ABBOTT MEDICAL 1014651 9163070

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other