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

Model Number 7600-0001

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The balloon therapy was beyond the labeled 6 month use and was administered using the ezfill dispenser.Multiple requests for the return of the device have been made but the device has not been investigated at this time.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.".

Event Description

On (b)(6) 2019, a physician reported a surgical removal of a deflated balloon from the small bowel of a patient.The reporting physician was not the prescribing physician and limited information is available at this time.The patient was administered three balloons approximately 9-10 months prior and had passed two balloons prior to being hospitalized.The patient did not have any post-operative complications and was discharged home in good health.

Manufacturer Narrative

The deflated balloon was not returned to obalon but was visually examined at the pathology lab in the hospital where the balloon was removed.A cut on the balloon was found that was most likely from the surgical removal and there were no visible signs of manufacturing defects.Evidence of fatigue along the balloon circumference was observed which is consistent with underinflated balloons.However, a fatigue hole could not be visually identified with the naked eye.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 9241347
• MDR Text Key: 167981046
• Report Number: 3009256831-2019-00225
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2019
• Device Model Number: 7600-0001
• Device Lot Number: 180327405
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/14/2019; 11/14/2019
• Supplement Dates FDA Received: 11/26/2019; 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention