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

Model Number 7600-0001

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

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 179 days.The balloon inflation pressures were recorded as within the acceptable pressure range at implantation and were administered using the ezfill dispenser.Obalon initiated a technical investigation of the product failure including an engineering analysis of the returned balloons.All balloon volumes were within the expected volume specification.The balloons were visually inspected with light microscopy and material fatigue was only observed on the deflated balloon.Scanning electron microscope (sem) images were obtained for the deflated balloon and a breach was identified in the area of the material fatigue.Deflation is a known risk, the frequency of balloon deflations has not exceeded the frequency identified in the labeling for on-label use.

Event Description

During a scheduled endoscopic removal procedure on (b)(6) 2019, two balloons were found inflated and one balloon was found partially deflated floating in the stomach.All balloons were successfully removed by endoscopy and were returned for investigation.The patient did not report a new onset of symptoms to their prescribing physician and had the first balloon placement on (b)(6) 2019, second balloon placement on (b)(6) 2019, and third balloon placement on (b)(6) 2019.

• 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: 9296315
• MDR Text Key: 190923503
• Report Number: 3009256831-2019-00228
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: (01)00859810006067
• 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: 10/10/2019

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: Health Professional
• Device Expiration Date: 12/19/2019
• Device Model Number: 7600-0001
• Device Lot Number: 181220404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• 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: 30 YR
• Patient Weight: 74