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); Abdominal Cramps (2543); No Information (3190)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

The balloon inflation pressure was not provided.The device therapy occurred over 337 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 one balloon placed.The balloon was placed on (b)(6) 2018 and the removal date was reported as (b)(6) 2019.It is unknown if the patient experienced symptoms or when the balloon was passed.The balloon was not returned to obalon for investigation and no serious injury occurred.

Manufacturer Narrative

Additional event information was obtained.The patient had two balloons placed with the first balloon placed on (b)(6) 2018 and second balloon placed on (b)(6) 2018.On (b)(6) 2019, the patient presented to the ed experiencing a new onset of cramping abdominal and severe rectal pain symptoms.A migrated balloon was located in the rectum and was removed on (b)(6) 2019.The remaining balloon was endoscopically removed the next day 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: 8570123
• MDR Text Key: 146195527
• Report Number: 3009256831-2019-00182
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 05/17/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 90