BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOCOLATE PTA BALLOON CATHETER

    MDR report key: 7534018 · Received May 21, 2018

    Report

    Report Number
    MW5077376
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 17, 2018
    Manufacturer
    TRIREME MEDICAL, LLC
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REMOVE CHOCOLATE BALLOON PTZ BALLOON CATHETER, IT WOULD NOT COME OUT AND PHYSICIAN PULLED HARD TO GET IT OUT. ONCE OUT IT WAS NOTICED THAT THE NITINOL JACKET WAS NO LONGER ATTACHED TO THE TIP. MANUFACTURER NOTIFIED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372813 CHOCOLATE PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL DQY TRIREME MEDICAL, LLC OTW F171114500

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention