MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/18/2020

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 balloon is introduced without incidents.When filling a leak of the saline solutions & methylene blue is noticed, and a rupture in the valve is confirmed.".

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 02/dec/2020.After multiple attempts to gather more information from the reporter, no additional information has been received.

• Brand Name: ORBERA 365 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: 10295508
• MDR Text Key: 199537084
• Report Number: 3006722112-2020-00064
• 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: 12/02/2020

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: 12/10/2021
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03407
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 85