BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 12779456 · Received November 9, 2021

    Report

    Report Number
    3011610434-2021-00019
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 14, 2021
    Report Date
    November 8, 2021
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLH
    UDI-DI
    10841898114304
    PMA / PMN Number
    K182386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE ON (B)(6) 2021 OF A REPORT FROM (B)(6) MEDICAL CENTER ON A SUPREME DIAGNOSTIC EP CATHETER THAT WAS INSERTED DOWN THE ESOPHAGUS OF A PATIENT DURING AN EP PROCEDURE. DURING THIS TIME, THE CURVE PROTECTOR OF THE DEVICE WAS NOT TAKEN OFF OF THE CATHETER AND WAS THEN LODGED DOWN THE PATIENT'S THROAT. THE PATIENT WAS TAKEN BACK TO THE RECOVERY ROOM, WHERE THEY WERE ABLE TO COUGH UP THE LODGED CURVED PROTECTOR. NO FURTHER MEDICAL INTERVENTION WAS REPORTED BY THE HOSPITAL. PER THE FEEDBACK RECEIVED FROM THE HOSPITAL, NO DEVICE MALFUNCTIONS WERE REPORTED WITH THIS DEVICE. THIS DEVICE WAS DISCARDED BY THE HOSPITAL PRIOR TO RETURNING THE DEVICE TO INNOVATIVE HEALTH FOR EVALUATION. FURTHERMORE, THE DEVICE DETAILS WERE UNAVAILABLE; THUS, A REVIEW OF THE ORIGINAL MANUFACTURING RECORDS WAS UNABLE TO BE PERFORMED. A REVIEW OF INNOVATIVE HEALTH'S INSTRUCTIONS FOR USE, IFU-EP-0008 REV. 2, WAS PERFORMED, AND THE IFU STATES "IF THE CATHETER IS PACKAGED WITH A CURVE PROTECTOR/RETAINER, REMOVE AND DISCARD."

    Description of Event or Problem · 0

    THIS DEVICE WAS REPORTEDLY IN USE DOWN THE ESOPHAGUS DURING AN EP PROCEDURE. DURING THIS TIME, THE TIP PROTECTOR WAS NOT TAKEN OFF OF THE CATHETER AND WAS LODGED DOWN THE PATIENT'S THROAT. THE PATIENT WAS TAKEN BACK TO THE RECOVERY ROOM, WHERE THEY WERE ABLE TO COUGH UP THE LODGED TIP PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676751 NA DIAGNOSTIC EP CATHETER NLH INNOVATIVE HEALTH, LLC. 401450 10841898114304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other