BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 8662962 · Received June 3, 2019

    Report

    Report Number
    3009256831-2019-00195
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 3, 2019
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    UDI-DI
    00859810006036
    PMA / PMN Number
    P160001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON THERAPY WAS BEYOND THE LABELED 6 MONTH USE. OBALON INITIATED A TECHNICAL INVESTIGATION OF THE PRODUCT FAILURE INCLUDING AN ENGINEERING ANALYSIS OF THE RETURNED BALLOONS. ALL BALLOON VOLUMES WERE WITHIN THE EXPECTED VOLUME SPECIFICATION. THE BALLOONS WERE VISUALLY INSPECTED WITH LIGHT MICROSCOPY AND MATERIAL FATIGUE WAS ONLY OBSERVED ON THE DEFLATED BALLOON. SCANNING ELECTRON MICROSCOPE (SEM) IMAGES WERE OBTAINED FOR THE DEFLATED BALLOON AND A BREACH WAS IDENTIFIED IN THE AREA OF THE MATERIAL FATIGUE. THE BREACH IN THE BALLOON IS THE LIKELY CAUSE FOR DEFLATION. DEFLATION IS A KNOWN RISK, THE FREQUENCY OF BALLOON DEFLATIONS HAS NOT EXCEEDED THE FREQUENCY IDENTIFIED IN THE LABELING FOR ON-LABEL USE. 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. PATIENTS SHOULD BE EVALUATED BY RADIOGRAPH AND ENDOSCOPIC VISUALIZATION MIGHT BE REQUIRED IF THE STATE OF INFLATION CANNOT BE DETERMINED RADIOGRAPHICALLY. IN THE EVENT OF BALLOON DEFLATION, THE BALLOON SHOULD BE REMOVED AS SOON AS POSSIBLE." "IT IS EXPECTED FOR PATIENTS TO EXPERIENCE SOME DEGREE OF NAUSEA, VOMITING, AND CRAMPING WITHIN THE FIRST WEEK AFTER EACH BALLOON ADMINISTRATION. SEVERE SYMPTOMS DURING THAT TIME OR NEW SYMPTOMS OCCURRING AFTER THE FIRST WEEK COULD INDICATE A PREMATURE BALLOON DEFLATION. A SUDDEN LOSS OF FULLNESS OR A SUDDEN INCREASE IN FEELINGS OF HUNGER MAY ALSO INDICATE A POTENTIAL BALLOON DEFLATION. IN THESE CIRCUMSTANCES, RADIOGRAPHIC IMAGING SHOULD BE CONSIDERED TO RULE OUT A POTENTIAL BALLOON DEFLATION. BALLOON VALVES ARE RADIOPAQUE AND THE OUTLINE OF AN INFLATED BALLOON WILL HAVE AN ELLIPTICAL OR CIRCULAR PERIMETER. IF ALL BALLOONS CANNOT BE VISUALIZED WITH A SINGLE X-RAY VIEW, A SECOND X-RAY VIEW SHOULD ALSO BE EVALUATED." "THE RISK OF BALLOON DEFLATION IS SIGNIFICANTLY HIGHER WITH BALLOONS THAT ARE LEFT LONGER THAN 6 MONTHS."

    Description of Event or Problem · 1

    A PATIENT WITH A FIRST BALLOON PLACEMENT IN (B)(6) OR (B)(6) 2018 PRESENTED TO AN ED ON (B)(6) 2019 WITH SEVERE NAUSEA, VOMITING, ABDOMINAL PAIN AND INTOLERANCE TO ORAL INTAKE THAT BEGAN FOUR DAYS PRIOR. DURING THE ENDOSCOPIC REMOVAL PROCEDURE ON (B)(6) 2019, TWO BALLOONS WERE FOUND INFLATED IN THE STOMACH AND ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE PYLORUS EXTENDING INTO THE DUODENAL BULB CAUSING A PARTIAL LUMINAL OBSTRUCTION. TWO 10 MM CLEAN BASED CRATERED ULCERS WERE FOUND IN THE ANTRUM AND PYLORUS, AND MULTIPLE CLEAN BASED ULCERS WERE FOUND IN THE DUODENAL BULB. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY AND WERE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458030 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC. 7500-0001 170428404 00859810006036

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR