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

Model Number B-40800

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.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 "difficulty adding/removing saline" and "difficulty with fill tube" are as follows: warnings and precautions: proper positioning of the placement catheter assembly and the orbera® system balloon within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.The orbera® system balloon is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The balloon must be handled only with gloved hands and with the instruments recommended in this document.Note: if the balloon becomes separated from the sheath prior to placement, do not attempt to use the balloon or reinsert the balloon into the sheath.Note: during the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: rapid fill rates will generate high pressure which can damage the orbera® system valve or cause premature detachment.

Event Description

The valve disconnected during filling and filling couldn't be completed.The balloon was removed early per the patient's anatomy it needed to be filled more.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 08/oct/2020.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 10/sept/2020.Non-deflated balloon returned with the fill tube disconnected from the slit valve.The sheath is present on the balloon and there is blue liquid present under the sheath and through-out the tubing.The fill tube tip was reinserted into the slit valve for testing.The end of the balloon was clamped onto the pull force equipment and it met minimum requirements.The crack pressure test could not be conducted due to several slits on the shell; therefore, an accurate reading could not be obtained.The fill tube was connected to the air pressure, the slits on the shell were covered and the balloon inflated and broke away the sheath as intended.Liquid was pushed through the slit valve and the flow of liquid was continuous and unobstructed.The balloon was inflated a second time; however, due to the numerous slits on the shell the balloon quickly deflated.Under microscopic analysis, the slits on the shell have striated edges which is consistent with a surgical instrument.The balloons thickness was measured and met specifications.The complaint could not be verified as functional testing did not find discrepancies with the returned balloon.

• Brand Name: BIB SYSTEM INTRAGASTRIC BALLOON
• 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: 10295215
• MDR Text Key: 199537633
• Report Number: 3006722112-2020-00062
• 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
• Report Date: 09/10/2020

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: 06/29/2021
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Device Lot Number: AF03019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR