MAUDE Adverse Event Report: OBALON THERAPEUTICS OBALON BALLOON SYSTEM

Model Number	7500
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Constipation (3274)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balloon burst while implanted in patient for 27 days.Product investigation on-going.No serious injury associated with event.Root cause of balloon burst/deflation remains unknown.Possibly related to use error/overpressurization of balloon at placement.Inflation pressures at placement not documented by physician staff.Initial testing suggests that peak pressures balloon exposed to where significantly higher than expected with a single inflation can.Second balloon in placement had an implantation time of 9 days without issue and was found fully inflated at removal.
Event or Problem Description
Patient had new onset of non-serious abdominal pain, nausea, vomiting and constipation lasting 4 days.After holiday patient contacted site.X-ray was conducted and one of two balloons was deflated due to a burst.Both balloons were removed as patient wanted to start a new series of balloons.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: OBALON
• Manufacturer (Section D): OBALON THERAPEUTICS; 5421 avenida encinas; suite f; carlsbad CA 92008
• MDR Report Key: 6759218
• Report Number: 3009256831-2017-00135
• Device Sequence Number: 1412349
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2017

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
• Operator of Device: Physician
• Device Expiration Date: 02/08/2018
• Device Model Number: 7500
• Device Lot Number: 170221403-0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 93