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

Model Number 7500

Device Problem Material Rupture (1546)

Patient Problem Nausea (1970)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

Obalon initiated a technical investigation of the product failure including full engineering analysis at obalon and, also, with a third-party failure analysis engineering firm.A breach in the balloon was observed and identified as the likely cause for deflation.Scanning electron microscope (sem) images were obtained.The sem data did not show any type of fatigue or material degradation in the area of the breach.This is the first failure of this type observed in commercial use.The initial investigation suggests that the preliminary root cause of the deflation was likely due to damage during the manufacturing process that was exacerbated upon exposure to the in vivo environment.To date the root cause of the event is an isolated event.Deflation is a known risk and the event has not exceeded the frequency identified in the labeling.Additionally, the user performs a leak test, checks the final balloon stabilization pressure, and must have access to an endoscopy suite per the instructions for use.Obalon's labeling addresses the reported event with warnings for monitoring patients for deflation symptoms.

Event Description

A female patient with a first balloon implantation date of (b)(6) 2017 had a second balloon placed on (b)(6) 2017.During the second balloon placement x-ray it was noticed that the first balloon was deflated and floating on top of the stomach fluids.The patient requested that only the deflated balloon be removed and that the inflated balloon remain implanted to continue with the balloon therapy.The deflated balloon was successfully removed by endoscopy from the patient's stomach without issue the next day.The deflated balloon was returned to obalon for investigation.The patient had experienced some nausea a few days prior to the second balloon placement but had thought it was mild in nature and did not contact their physician.There was no serious injury due to the deflated balloon.The first balloon implantation medical record was requested and the balloon inflation pressure and stabilization were not recorded.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.

• 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: alyssa antolak ; 5421 avendia encinas; suite f; carlsbad, CA 92008 ; 7606075188
• MDR Report Key: 6998515
• MDR Text Key: 92049842
• Report Number: 3009256831-2017-00277
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/10/2018
• Device Model Number: 7500
• Device Lot Number: 170111404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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: 41 YR
• Patient Weight: 98