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

Model Number 7500-0001

Device Problem Short Fill (1575)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

The balloon was implanted for 20 days.The deflated balloon that was removed from the stomach was returned to obalon for analysis.The inflation catheter was discarded and not returned to obalon.Obalon visually inspected the balloons with light microscopy and no material fatigue was observed and the volume was measured to be within specification.The balloon did not have any breaches except for the grasper holes from the removal procedure.The balloon implantation medical record information was requested and balloon inflation pressures were not recorded.No serious injury was associated with the event.A probable root cause is that the patient bit the catheter during the administration swallow.Based on the fact that the patient felt something in their throat during inflation and water in their mouth during ejection, there was a potential breach in the catheter resulting in the balloon which could not be ejected.The balloon was most likely venting to atmospheric pressure for an extended period of time before the catheter was finally removed from the balloon.A breach in the closed loop gas pathway leads to balloon depressurization leaving an underinflated balloon in the body which can result in balloon deflation.Additionally, the balloon kit was 22 days past the labeled expiration date on the administration date based on the returned balloon lot information.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.The investigation suggests that the preliminary root cause of the deflation was likely due low balloon pressure most likely from a breach in the catheter due to a potential bite from the patient during administration.

Event Description

A female patient was administered their first balloon on (b)(6) 2018.During balloon inflation the patient felt something in the back of her neck.The balloon was imaged as in the stomach with no observations in the neck area.The inflation catheter did not eject from the balloon and the patient felt water in her mouth.Endoscopy was performed with the balloon kit detached from the dispenser and open to atmosphere.The physician felt that the balloon was sufficiently inflated based on the radiographic images and pulled the catheter off the balloon.The balloon pressure displayed on the ezfill dispenser was unknown and not used to make the decision that the balloon was sufficiently inflated as described in the instructions for use.The administering physician's technician stated the patient had struggled to swallow the balloon.The final balloon pressure after stabilization was not recorded and the inflation catheter was discarded.On (b)(6) 2018, obalon was notified of this event and obalon explained the risk of an underinflated balloon, recommended that the balloon be removed endoscopically according to the labeling, and that the patient be notified of the deflation risk and be aware of deflation symptoms.The balloon was not removed and the physician stated the patient would monitor their symptoms.The patient was examined by imaging on (b)(6) 2018 and the radiology report stated there was a questionable artifact in the hepatic flexure of the colon.However, the patient did not see the balloon in their stool.On (b)(6) 2018, the patient reported that she was not as full when eating smaller portions.The patient had a scheduled appointment on (b)(6) 2018 to receive another balloon.On (b)(6) 2018, the balloon was found deflated in the stomach and was removed without issue by endoscopy.The patient did not experience symptoms of cramping, nausea or vomiting.The patient had lost 7 lbs and there was no patient injury reported.The deflated balloon was returned to obalon.The patient received another balloon to continue the device therapy.

• 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: 7442343
• MDR Text Key: 106712686
• Report Number: 3009256831-2018-00188
• Device Sequence Number: 1
• Product Code: LTI
• 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: 04/18/2018

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: Physician
• Device Expiration Date: 02/20/2018
• Device Model Number: 7500-0001
• Device Lot Number: 170221403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• 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: 44 YR
• Patient Weight: 117