MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Implant Pain (4561)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: the current orbera365" intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "deflation" and device appearance - post operative" as follows: warnings and precautions: deflated devices should be removed promptly.If it is necessary to replace a balloon which has spontaneously deflated, the recommended initial fill volume of the replacement balloon is the same as for the first balloon or the most recent volume of the removed balloon.A greater initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.Possible complications of the use of the orbera365" system include: balloon deflation and subsequent replacement.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."possible complications of the use of the orbera system include: injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.

Event Description

Patient presented with pain.Ultrasound was perfrom and it was found the balloon was empty.The balloon was successfully removed.

• Brand Name: ORBERA365 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 11921806
• MDR Text Key: 255177103
• Report Number: 3006722112-2021-00042
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 63