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

Model Number B-40800

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.Apollo has not received the product at this time.Therefore no analysis or testing has been done.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 event of "deflation" as follows: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc).The physiological response of the patient to the presence of the orbera365¿ 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, acute pancreatitis, spontaneous inflation, 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 orbera365¿ system include: balloon deflation and subsequent replacement.

Event Description

Health professional reported via product field notes (pfn), "catheter got detached after 50cc of filling.".

Manufacturer Narrative

The device was returned to the apollo device analysis laboratory on 22/nov/2019.Analysis of the device is ongoing.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 31/jan/2020.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 22/nov/2019.The balloon was returned with blue liquid present and the sheath is partially attached.The fill tube was not returned for evaluation.Per engineering, the sheath ripped and fully separated at only 50 cc which is unusual.The fill opening pressure looks normal; however, the shell thickness near valve is out of spec and the balloon feels very rigid around the valve section.

• 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 78746
• MDR Report Key: 9447387
• MDR Text Key: 183976530
• Report Number: 3006722112-2019-00191
• 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,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Device Lot Number: AF02893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1