MAUDE Adverse Event Report: OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM; INTRAGASTIC BALLOON

Model Number 7600-0002

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Abdominal Cramps (2543); No Information (3190)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

The balloon inflation pressures were not provided.The device therapy occurred over 225 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.".

Event Description

Obalon was notified by a physician in the middle east that a single balloon migrated (passed) in a patient with three 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.

Manufacturer Narrative

Additional event information was obtained.The patient had the first balloon placed on (b)(6) 2018, second balloon placed on (b)(6) 2018, and third balloon placed on (b)(6) 2018.On (b)(6) 2019, the patient experienced a new onset of cramping abdominal pain and vomiting symptoms and presented to the ed.A ct scan of the abdomen showed a single balloon in the jejunum and the patient was discharged.The patient had the remaining two balloons in the stomach endoscopically removed on (b)(6) 2019.During the removal appointment the patient reported rectal pain and x-ray imaging showed a single balloon in the rectum.The patient was instructed to take a laxative and the patient notified the prescribing physician that the balloon had passed on (b)(6) 2019.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• Manufacturer (Section G): OBALON THERAPEUTICS, INC.; 5421 avenida encinas; suite f; carlsbad CA 92008
• Manufacturer Contact: amy vandenberg ; 5421 avendia encinas; suite f; carlsbad, CA 92008 ; 7607956551
• MDR Report Key: 8570160
• MDR Text Key: 146195486
• Report Number: 3009256831-2019-00183
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: QA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7600-0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 69