BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK

    MDR report key: 16901647 · Received May 10, 2023

    Report

    Report Number
    16901647
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN ANGIOPLASTY, A BALLOON CATHETER BECAME STUCK INSIDE THE PATIENT, AS DESCRIBED BY A STAFF MEMBER. THE BALLOON WAS AN ABBOTT 4.00X15 NC TREK RX (LOT #: 21111G1; REF #: 1012453-15). THE PHYSICIAN WAS UNABLE TO REMOVE THE CATHETER VIA THE GUIDE CATHETER. THE PHYSICIAN HAD TO REMOVE THE GUIDE CATHETER AND THE WIRE TO REMOVE THE BALLOON FROM THE PATIENTS BODY. IT APPEARED THAT NO HARM WAS CAUSED TO THE PATIENT, AND THE BALLOON CATHETER WAS SAVED AND SENT BACK TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231897 NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1012453-15 21111G1

    Patients

    Seq Age Sex Outcome Treatment
    1 33215 DA Female