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

Model Number 7600-0002

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Abdominal Cramps (2543)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Balloon administration information was requested and it was stated that the balloon pressure was within the labeled range and that balloon stabilization was performed for 30 seconds, however per the ifu, two 30 second stabilization periods are included with the ezfill dispenser valve open and closed.Obalon initiated a technical investigation of the product failure including an engineering analysis of the returned deflated balloon.The balloon was visually inspected with light microscopy and material fatigue was observed.Scanning electron microscope (sem) images were obtained and a breach was identified in the area of the material fatigue.No other breaches were identified in the balloon to cause a leak source.The breach in the balloon is the likely cause for deflation.The investigation suggests that the probable root cause of the deflation was likely due to underinflation at administration.Obalon's labeling addresses this type of 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

On (b)(6) 2019, a single deflated balloon was surgically removed from a patient because it caused an intestinal obstruction and intestinal perforation.The balloons were administered in the middle east and were implanted for less than 3 weeks with a first balloon placement of (b)(6) 2019 and second balloon placement of (b)(6) 2019.The patient experienced cramping and abdominal pain 5 days after the second balloon administration.The patient was discharged from the hospital and remains stable with no clinical sequelae and continued the balloon therapy with the remaining implanted balloon.

Manufacturer Narrative

On august 21, 2019 obalon was notified that the ezfill dispenser used to inflate the balloon that had subsequently deflated while implanted was not displaying the proper pressure reading when prepared for a balloon administration.The device was returned and investigated.During preparation of the dispenser it stabilized at a pressure well below the labeled stabilization pressure range.A simulated balloon inflation in a water bath was performed and the balloon was severely underinflated.The investigation confirms that the probable root cause of the deflation was likely due to underinflation at administration.Obalon's labeling addresses this type of reported event with warnings for monitoring patients for deflation symptoms, verification of the dispenser pressure prior to administering the balloon, and verification that the final balloon pressure is stable and between 9.0 - 13.0 kpa when implanted.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 8866466
• MDR Text Key: 153447690
• Report Number: 3009256831-2019-00213
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 7600-0002
• Device Lot Number: 180614404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 07/07/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 07/07/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Weight: 110