MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Fluid/Blood Leak (1250)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: the current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "deflation" as follows: the physiological response of the patient to the presence of the orbera system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Deflated devices should be removed promptly.Complications: possible complications of the use of the orbera system include: balloon deflation and subsequent removal.

Event Description

Reported as: "the balloon was completely collapsed and empty ".

Manufacturer Narrative

Supplement #2 - medwatch submitted to the fda on 28/sept/2020.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 8/june/2020.One deflated balloon with a large tear on the shell was returned for evaluation.The balloon shows significant brown discoloration.The large tear on the balloon shows inward rolling of the shell with few areas of striated edges.The striated edges are more than likely related to a surgical instrument for removal purposes.Due to the extensive damage of the returned balloon, there was no functional evaluation conducted.The complaint has been verified and it is uncertain how the opening on the shell occurred.

Manufacturer Narrative

Supplement #1 - medwatch submitted to the fda on 7/jul/2020.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• MDR Report Key: 10128355
• MDR Text Key: 194330080
• Report Number: 3006722112-2020-00058
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2020

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: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF02411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 06/08/2020; 06/08/2020
• Supplement Dates FDA Received: 07/07/2020; 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 103