BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE

    MDR report key: 18649672 · Received February 6, 2024

    Report

    Report Number
    18649672
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    September 22, 2023
    Report Date
    October 13, 2023
    Manufacturer
    COOK INCORPORATED
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE REMOVING BALLOON FROM WIRE, DOCTOR MET RESISTANCE AND WAS UNABLE TO REMOVE THE BALLOON. UPON FURTHER INSPECTION UNDER FLUORO, NOTED THE BALLOON TO BE STUCK INSIDE THE ANSEL SHEATH THAT HAD BEEN PLACED IN PATIENT'S RIGHT GROIN. DOCTOR THEN REMOVED THE SHEATH WITH BALLOON INSIDE AND INSPECTED THE BALLOON ON THE STERILE FIELD. DOCTOR NOTED THE BALLOON TO BE NOT INTACT. ANSEL SHEATH REPLACED WITH NEW SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504536 ADVANCE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INCORPORATED G30952 14942280

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female