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

Model Number 7500

Device Problem Material Perforation (2205)

Patient Problem Abdominal Cramps (2543)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

The deflated balloon was the first balloon implanted of the three balloon system and was implanted for a duration of 211 days.The balloon removal occurred 28 days beyond 6 months from the first balloon placement.The balloon inflation pressures were not recorded at placement but the case was described as normal and that the balloon was inflated within the pressure ranges.The deflated balloon was returned to obalon for analysis.Obalon initiated a technical investigation of the product failure including full engineering analysis at obalon, with a third-party failure analysis engineering firm, and, also, a third-party laboratory for culture analysis.The balloon volume was within the expected volume specification.The culture analysis results on sample swabs from the balloon showed no detectable evidence of bacteria and the limited fungi identified are commonly identified in the gut flora or commonly found in baked goods, alcohol, protein supplements, and energy boosters.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 from the third-party laboratory shows a defect in the area of the breach located in the hemisphere of the balloon; however, the root cause investigation for the material breach remains on-going.Obalon's labeling addresses the reported event with warnings for monitoring patients for deflation symptoms, to remove balloons 6 months after the first balloon was placed, and that the risk of deflation is significantly higher with balloons that implanted longer than 6 months.No serious injury was associated with the event.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.Each patient should be monitored closely during the entire device therapy period in order to detect the development of possible complications.Patients should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, esophageal injury, and other possible complications that could occur, and should be advised to contact their physician if these symptoms worsen over time or persist for more than 24 hours.All three balloons are removed 6 months after the first balloon was placed.The balloons are only intended to remain in the stomach for 6 months from the time of placement of the first balloon.All balloons placed must be removed at the end of 6 months after placement of the first balloon using endoscopy per the specified tool dimensions.All balloons must be removed 6 months after the first balloon is placed.The risk of balloon deflation is significantly higher with balloons that are left longer than 6 months.After 6 months from the first implantation, all balloons must be removed from the patient.

Event 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 had a routine scheduled removal on (b)(6) 2018.The scheduled removal date was more than 6 months from the first balloon placement.During the removal procedure, one balloon was identified as deflated and was located in the stomach.The deflated balloon was successfully removed by endoscopy without complication.The stomach appeared normal.The patient had experienced a new onset of minor cramping at night when falling asleep about one week prior to the removal.There was no serious injury due to the deflated balloon.The patient was doing well after the removal with no issues post removal.The deflated balloon was returned to obalon for investigation.

• 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: 7293252
• MDR Text Key: 101014426
• Report Number: 3009256831-2018-00050
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2018

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
• Device Operator: Physician
• Device Expiration Date: 05/01/2018
• Device Model Number: 7500
• Device Lot Number: 170502404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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: 40 YR
• Patient Weight: 79