MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-50000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 10/31/2020

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 21/dec/2020.The reporter noted that the device will not be returned for analysis.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 events 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." "complications: possible complications of the use of the orbera system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.Deflation and subsequent replacement." "deflated device should be removed promptly.".

Event Description

The balloon deflated, and was removed successfully.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 11046621
• MDR Text Key: 223176012
• Report Number: 3006722112-2020-00130
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020541
• UDI-Public: (01)10811955020541(17)2021-10-23(10)AF03294
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2020

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: 10/23/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF03294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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: 33 YR
• Patient Weight: 86