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

Model Number 7600

Device Problems Material Puncture/Hole (1504); Short Fill (1575)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The returned catheter was analyzed by optical microscopy and a bite mark with a breach was identified.A breach in the closed loop gas pathway can lead to balloon depressurization resulting in the potential of an underinflated balloon in the patient.Underinflated balloons are known to potentially result in balloon deflation.Obalon's labeling addresses the reported event with warnings for monitoring patients for deflation symptoms and to verify that the final balloon pressure is stable and between 9.0 - 13.0 kpa.

Event Description

A female patient with a first balloon placement of (b)(6) 2018, a failed second balloon placement on (b)(6) 2018, due to the patient biting the catheter during administration, received another second balloon placement procedure on (b)(6) 2018.The balloon capsule was swallowed and inflated during this balloon placement, however, after balloon inflation, the balloon pressure began decreasing.The last observed balloon pressure on the ezfill dispenser prior to catheter ejection was 8.8 kpa which is outside of the labeled balloon inflation pressure range.Representatives from obalon recommended that the physician remove the balloon endoscopically according to the labeling.The catheter was returned to obalon for investigation.A patient x-ray was performed on (b)(6) 2018 during the third balloon placement that indicated all three balloons were inflated.On (b)(6) 2018, the physician communicated to obalon that they decided to leave the second balloon implanted and monitor the patient via x-ray.The patient was scheduled for a two-week follow-up, however was unable to make the appointment.During a one-month follow-up by phone with the prescribing physician, the patient was doing well and had no hunger symptoms.The patient is scheduled for an appointment during the week of (b)(6) 2018 and x-ray is planned to be performed.To date, the balloon has not been removed and no patient injury has been reported.

Manufacturer Narrative

Additional information: all three balloons were visualized as inflated via endoscopy during the scheduled removal on (b)(6) 2018.No balloons were deflated and all were successfully removed.Additionally, there were no patient side effects, the stomach and esophagus were healthy, and the patient lost 41 lbs.The balloons were returned to obalon for investigation on august 9, 2018 and inspected on august 13, 2018.The balloon which had been underinflated to 8.8 kpa was visually inspected as normal and the balloon volume was within specification.

Manufacturer Narrative

Awareness date typographical error corrected from 05/19/2018 to 04/19/2018.

• 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 avendia encinas; suite f; carlsbad CA 92008
• Manufacturer Contact: amy vandenberg ; 5421 avendia encinas; suite f; carlsbad, CA 92008 ; 7607956551
• MDR Report Key: 7525984
• MDR Text Key: 108732641
• Report Number: 3009256831-2018-00146
• 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,Followup,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/22/2018
• Device Model Number: 7600
• Device Lot Number: 171003402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/19/2018; 04/19/2018
• Supplement Dates FDA Received: 08/23/2018; 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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: 68 YR
• Patient Weight: 95