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

Model Number	7500
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deflated balloon was the first balloon implanted of the three-balloon system and was implanted for a duration of 185 days.The balloon inflation pressure was recorded as within the pressure range at implantation.The deflated balloon was returned to obalon for analysis.Obalon initiated a technical investigation of the product failure including full engineering analysis at obalon and a third-party laboratory for culture analysis.The balloon volume was within the expected volume specification.The culture analysis results from sample swabs from the balloons showed detection of bacteria, one which is often used as a probiotic, and limited fungi which are commonly identified in the gut flora and gastrointestinal tract.Breaches in the balloon were observed and identified as the likely cause for deflation.Obalon visually inspected the balloons with light microscopy and material fatigue was observed.Scanning electron microscope (sem) images were obtained.The sem data and interim investigation results shows a defect in the area of the breach of the balloon; however, the root cause investigation for the material breach remains ongoing.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.No serious injury was associated with the event.
Event or Problem Description
A female patient with a first balloon implantation date of (b)(6) 2017, second balloon placement of (b)(6) 2017, and third balloon placement of (b)(6) 2017, experienced a new onset of symptoms of nausea since approximately (b)(6) 2018 and reported new symptoms to the prescribing physician.The planned balloon removal scheduled for (b)(6) 2018 was moved to (b)(6) 2018.During endoscopy, one balloon was identified as deflated in the antrum of the stomach.The deflated balloon was successfully removed by endoscopy without complication.Slight antral gastritis was observed.The patient was stable and later discharged home.There was no serious injury due to the deflated balloon.The patient lost 57 pounds during the treatment from a starting bmi of (b)(6).The deflated balloon was returned to obalon for investigation.

• 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: 7487561
• Report Number: 3009256831-2018-00224
• Device Sequence Number: 16425264
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: Physician
• Device Expiration Date: 01/17/2018
• Device Model Number: 7500
• Device Lot Number: 170118406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 102