MAUDE Adverse Event Report: OBALON THERAPEUTICS OBALON BALLOON SYSTEM

Model Number 7500

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Constipation (3274)

Event Date 07/05/2017

Event Type  malfunction  

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 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
• Type of Device: OBALON
• Manufacturer (Section D): OBALON THERAPEUTICS; 5421 avenida encinas; suite f; carlsbad CA 92008
• Manufacturer (Section G): OBALON THERAPEUTICS; 5421 avenida encinas; suite f; carlsbad CA 92008
• Manufacturer Contact: amy vandenberg ; 5421 avenuda encinas; suite f; carlsbad, CA 92008 ; 7607956551
• MDR Report Key: 6759218
• MDR Text Key: 81721335
• Report Number: 3009256831-2017-00135
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• 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: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/01/2017
• 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: 23 YR
• Patient Weight: 93