BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 8570090 · Received May 1, 2019

    Report

    Report Number
    3009256831-2019-00181
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    March 7, 2019
    Report Date
    May 15, 2019
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON INFLATION PRESSURES WERE NOT PROVIDED. THE DEVICE THERAPY OCCURRED OVER 213 DAYS WHICH IS BEYOND THE LABELED 6 MONTH USE. A POTENTIAL ROOT CAUSE OF THE DEFLATION COULD HAVE BEEN MATERIAL FATIGUE RESULTING FROM LOW BALLOON PRESSURE, HOWEVER THE ACTUAL ROOT CAUSE REMAINS UNKNOWN. PER THE LABELING "PATIENTS REPORTING A LOSS OF FULLNESS, INCREASED HUNGER, AND/OR WEIGHT GAIN SHOULD BE EXAMINED BY RADIOGRAPH, AS THIS MAY BE A SIGN OF BALLOON DEFLATION. ADDITIONALLY, ANY INCREASE IN NAUSEA, VOMITING AND/OR CRAMPING AFTER INITIAL SYMPTOMS HAVE SUBSIDED MAY INDICATE A DEFLATED BALLOON. ENDOSCOPIC VISUALIZATION MIGHT BE REQUIRED IF THE STATE OF INFLATION CANNOT BE DETERMINED RADIOGRAPHICALLY. EVIDENT BALLOON DEFLATION MAY REQUIRE EARLY BALLOON REMOVAL". THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING WARNING: "THE RISK OF BALLOON DEFLATION IS SIGNIFICANTLY HIGHER WITH BALLOONS THAT ARE LEFT LONGER THAN 6 MONTHS".

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVENT INFORMATION WAS OBTAINED. THE PATIENT HAD THE FIRST BALLOON PLACED ON (B)(6) 2018 AND THE SECOND BALLOON PLACED ON (B)(6) 2018. THE PATIENT EXPERIENCED A NEW ONSET OF SYMPTOMS OF CRAMPING AND A SINGLE BALLOON MIGRATED (PASSED) ON (B)(6) 2019. THE REMAINING BALLOON WAS ENDOSCOPICALLY REMOVED ON (B)(6) 2019.

    Description of Event or Problem · 1

    OBALON WAS NOTIFIED BY A PHYSICIAN IN THE MIDDLE EAST THAT A SINGLE BALLOON MIGRATED (PASSED) IN A PATIENT WITH TWO BALLOONS PLACED. THE FIRST BALLOON WAS PLACED ON (B)(6) 2018 AND THE OVERDUE REMOVAL OCCURRED ON (B)(6) 2019. IT IS UNKNOWN IF THE PATIENT EXPERIENCED SYMPTOMS OR WHEN THE BALLOON WAS PASSED. THE BALLOONS WERE NOT RETURNED TO OBALON FOR INVESTIGATION AND NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364932 OBALON BALLOON SYSTEM INTRAGASTRIC BALLOON LTI OBALON THERAPEUTICS, INC. 7600-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR