BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOCOLATE PTA BALLOON CATHETER

    MDR report key: 7637702 · Received June 25, 2018

    Report

    Report Number
    MW5078034
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 21, 2018
    Manufacturer
    TRIREME MEDICAL INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CHOCOLATE PTA BALLOON CATHETER WAS INSERTED INTO PATIENT'S SFA TO BALLOON. AFTER BALLOON WAS DEFLATED IT GOT HUNG UP ON THE STENT AND THE BALLOON BROKE OFF THE SHAFT AS IT WAS BEING REMOVED OVER THE WIRE. THE BALLOON WAS SUCCESSFULLY RETRIEVED AND REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475084 CHOCOLATE PTA BALLOON CATHETER BALLOON CATHETER LIT TRIREME MEDICAL INC. F170922500

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention