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

Model Number	7600-0001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deflated balloon administration date is unknown since the balloon traceability information was not provided but it was implanted for a minimum duration of 182 days based on the third balloon placement date.The balloon inflation pressures were requested but not provided.Obalon initiated a technical investigation of the product failure including full engineering analysis at obalon and a third-party laboratory for culture analysis on the returned deflated balloon.The balloon volume was within the expected volume specification.The culture analysis results from sample swabs from the balloon showed detection of bacteria naturally found in the intestinal tract, and fungi commonly identified in the gut flora.Obalon visually inspected the balloon with light microscopy and material fatigue was observed on the deflated balloon and a breach was identified in the area of the material fatigue.The initial investigation suggests that the preliminary root cause of the deflation was likely due to damage during the manufacturing process that was an isolated event and 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.Obalon's labeling addresses the reported event with warnings for monitoring patients for deflation symptoms.Obalon's 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.".
Event or Problem Description
A male 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 was found to have one of three balloons deflated in the stomach during the scheduled routine endoscopic removal on (b)(6) 2018.The physician reported that the patient experienced a new onset of symptoms of abdominal pain.All balloons were successfully removed by endoscopy without complication and the deflated balloon was returned to obalon for investigation.There was no serious injury due to the deflated balloon.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 8071408
• Report Number: 3009256831-2018-00691
• Device Sequence Number: 16626546
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: 00859810006067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2018
• Device Model Number: 7600-0001
• Device Lot Number: 171127406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR