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

Model Number B-50000

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 10/05/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.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 "broken device" as follows: warnings and precautions: when filling the balloon during the placement procedure, avoid rapid fill rates as these will generate high pressure which can damage the orbera¿ valve or cause premature detachment of the balloon from the placement catheter.Proper positioning of the placement catheter assembly and the orbera¿ balloon within the stomach (using measured distance from the incisors via the insertion tube markings) is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.Failure to confirm proper positioning may cause injury to the esophagus, duodenum, or pylorus.If difficulty with the orbera¿ fill tube is noted during placement (e.G., resistance to balloon filling), then the device should be removed and replaced with a new balloon.To lessen, or prevent fill tube defects, during the filling process the fill tube must remain slack.If the fill tube is under tension during this process, the fill tube may dislodge from the balloon, preventing further balloon deployment.During the filling process the fill tube must remain slack.If the fill tube is under tension during this process the fill tube may dislodge from the balloon preventing further balloon deployment.

Event Description

Reported complaint: "there was a leakage at the time of implant observed under direct vision.".

Manufacturer Narrative

Supplement #1-medwatch submitted to the fda on 31/mar/2020.Additional information: d10, h3, h6, h10.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 6/march/2020.A deflated balloon blue in color was returned without the fill tube.As the device was not received with the fill tube, a sample fill tube was used for device testing.The sample fill tube was inserted into the slit valve and there were no blockages and the flow of air and liquid was continuous and unobstructed.After inflation it was observed that there is a small leak which causes slow deflation of the balloon.Under microscopic analysis, there is a small hole approximately the size of a pen tip on the shell.The complaint has been verified as it is inconclusive when or how the hole was punctured on the shell.

• 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 78746
• MDR Report Key: 9476700
• MDR Text Key: 183977859
• Report Number: 3006722112-2019-00185
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF03011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FENTANOL.; MIDAZOLAN.; PROPOFOL.
• Patient Age: 46 YR
• Patient Weight: 90