BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 8547183 · Received April 24, 2019

    Report

    Report Number
    3009256831-2019-00145
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 22, 2019
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    UDI-DI
    00859810006067
    PMA / PMN Number
    P160001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFLATED BALLOON WAS THE FIRST BALLOON IMPLANTED OF THE THREE-BALLOON SYSTEM AND WAS IMPLANTED FOR A DURATION OF 171 DAYS. THE BALLOON INFLATION PRESSURE WAS RECORDED AS WITHIN THE ACCEPTABLE PRESSURE RANGE AT IMPLANTATION. 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. THE INITIAL INVESTIGATION SUGGESTS THAT THE PRELIMINARY ROOT CAUSE OF THE DEFLATION WAS LIKELY DUE TO DAMAGE DURING THE MANUFACTURING PROCESS THAT WAS EXACERBATED UPON EXPOSURE TO THE IN VIVO ENVIRONMENT. DEFLATION IS A KNOWN RISK, THE FREQUENCY OF BALLOON DEFLATIONS HAS NOT EXCEEDED THE FREQUENCY IDENTIFIED IN THE LABELING. THE PRODUCT LABELING ADDRESSES THE REPORTED EVENT WITH WARNINGS FOR MONITORING PATIENTS FOR DEFLATION SYMPTOMS. THE LABELING STATES, "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." AND "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".

    Description of Event or Problem · 1

    A PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018 HAD A REMOVAL SCHEDULED ON (B)(6) 2019 BUT CONTACTED THEIR PRESCRIBING PHYSICIAN'S OFFICE ON (B)(6) 2019 TO REQUEST AN EARLIER BALLOON REMOVAL. ON (B)(6) 2019 THE PATIENT REPORTED EXPERIENCING SEVERE ABDOMINAL PAIN AND THE PATIENT WAS INSTRUCTED GO TO THE ED IF THE PAIN WAS SEVERE, HOWEVER, THE PATIENT REQUESTED MEDICATIONS AND DECLINED TO GO TO THE ED. THE ENDOSCOPIC REMOVAL WAS SCHEDULED FOR (B)(6) 2019. DURING RETRIEVAL, ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE STOMACH AND MULTIPLE SUPERFICIAL NON-BLEEDING ULCERS RANGING IN SIZE FROM 10 TO 15 MM AND ERYTHEMA COMPATIBLE WITH GASTRITIS WERE FOUND IN THE ANTRUM. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND WERE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338511 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC. 7600-0001 180731404 00859810006067

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR