BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 4949002 · Received July 27, 2015

    Report

    Report Number
    1722684-2015-00004
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 22, 2015
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    OQY
    PMA / PMN Number
    K091958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE INCIDENT WAS ONLY RETURNED TO CLINICAL INNOVATIONS FOR EVALUATION ON (B)(6) 2015. THE INSPECTION OF THE DEVICE REVEALED THAT THE BALLOON MATERIAL HAD FAILED, CAUSING THE LEAK. THE DAMAGE INSPECTED WAS CONSISTENT W/ A POSSIBLE ANEURYSM OCCURRING IN THE BALLOON MATERIAL WHEN THE DEVICE WAS BEING EXTRUDED OUT OF THE CERVIX AFTER THE INITIAL INSERTION AND INFLATION. UPON RE-INSERTION OF THE DEVICE, THIS ANEURYSM PRESENT ON THE BALLOON MATERIAL APPEARS TO HAVE FAILED AS THE BALLOON WAS BEING RE-INFLATED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE UTERINE BALLOON OF THE EBB COMPLETE TAMPONADE SYSTEM WAS PLACED W/ OUT DIFFICULTY INTO THE UTERUS OF THE PATIENT. AFTER THE BALLOON WAS FILLED, HOWEVER, IT WAS NOTED THAT THE BALLOON BEGAN TO EXTRUDE BACK THROUGH THE CERVIX. THE BALLOON WAS DEFLATED & RE-INSERTED. UPON RE-INFLATION OF THE BALLOON, IT WAS NOTED THAT FLUID WAS ESCAPING FROM THE VAGINA AT APPROXIMATELY 300 ML FILL. A VAGINAL EXAM INDICATED THAT THE UTERINE BALLOON HAD DEFLATED. A SECOND DEVICE WAS USED SUCCESSFULLY. THE PATIENT WAS MOVED TO THE ICU AND RECEIVED A BLOOD TRANSFUSION. THE HEALTHCARE PROF COULD NOT DEFINITIVELY CONFIRM THAT THE ISSUE W/THE FIRST EBB COMPLETE TAMPONADE SYSTEM USED W/THE PATIENT WAS DIRECTLY INVOLVED IN THE MOVEMENT OF THE PATIENT TO THE INTENSIVE CARE UNIT. THE PATIENT FULLY RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487501 EBB COMPLETE TAMPONADE SYSTEM EBB COMPLETE TAMPONADE SYSTEM OQY CLINICAL INNOVATIONS, LLC 1214-V-424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention