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

Model Number 7600-0001

Device Problems Leak/Splash (1354); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation confirms that the probable root cause of the deflation was likely due to underinflation at administration which could not be identified via fluoroscopy at administration.The cause of the underinflation is unknown in particular since the device was not returned, however, there could have been a leak in the system from a bit catheter, loose connection, or device defect.Deflation is a known risk in particular when the balloon is not properly inflated.Obalon's labeling addresses this type of event with warnings for verification that the final balloon pressure is stable and between 9.0 - 13.0 kpa when implanted and that partial deflations may not be visible on x-ray until a substantial portion of gas has left the balloon.Per the labeling, underinflated balloons have also resulted from catheter breaches from bitten tubing.If the balloon is not properly inflated and not identified as underinflated, there is a risk for small bowel obstructions.If you suspect damage to the catheter the balloon must be removed endoscopically.In the event the balloon pressure does not fall within this range you will have to remove the balloon endoscopically.

Event Description

Only two inflated balloons were identified in the stomach during a scheduled 6-month endoscopic removal on (b)(6) 2020 for a patient with three balloons implanted.A ct scan on (b)(6) 2020 showed no foreign body identified in the patient therefore the patient likely passed the missing balloon.The patient did not report any symptoms or identify the balloon that passed.The two inflated balloons in the stomach were returned to obalon for investigation and it was confirmed through lot tracing of the balloon valve that the third balloon administered was the missing balloon.The missing balloon was the third balloon which was administered on (b)(6) 2019 using the ezfill dispenser and the administration record documented the final balloon pressure as 4.4 kpa which is well below the labeled final balloon pressure per the instructions for use.During the investigation the administering physician noted that the balloon was initially inflated up to the appropriate pressure; however, it did not stabilize in the proper pressure range during the 30 second leak check, and subsequently had dropped to 4.4 kpa.The 1st and 2nd balloons were inflated with stable inflation pressures of 12.3 kpa and 11.8 kpa, respectively.All three balloons were fluoroscopically visualized after inflation at administration and despite the unstable pressure of the 3rd balloon the physician felt that visually the balloon seemed inflated.Per the instructions for use the balloon should be removed if the balloon pressure is below 9.0 kpa and is not stable at the 30 second leak check as defined as does not change more than 0.3 kpa.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad, ca
• Manufacturer (Section G): OBALON THERAPEUTICS, INC.; 5421 avenida encinas; suite f; carlsbad, ca
• Manufacturer Contact: amy vandenberg ; 5421 avendia encinas; suite f; carlsbad, ca ; 7956551
• MDR Report Key: 9914581
• MDR Text Key: 208331149
• Report Number: 3009256831-2020-00007
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: 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: 03/06/2020

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: 03/04/2020
• Device Model Number: 7600-0001
• Device Lot Number: 190305403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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: 49 YR
• Patient Weight: 100