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

Model Number B-50000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/28/2019

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 orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "difficulty with fill tube" as follows: "precautions: 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." "warnings: 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." "orbera® is composed of a 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 for removal." "caution: 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." "caution: 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." "warning: rapid fill rates will generate high pressure which can damage the orbera® valve or cause premature detachment." the labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint for this product will be reviewed in the next complaints analysis meeting (cam).

Event Description

Health professional reported via product field notes (pfn), "at the time of balloon placement, the balloon had disconnected between the valve and the catheter.".

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.Received one non-inflated balloon with the fill tube disconnected from the slit valve.The sheath is still present and there is no liquid inside balloon.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 met minimum requirements.The fill tip pressure to inflate the balloon met minimum requirements as well.The balloon was fully inflated, and the sheath broke away as intended.The inflated balloon was then submerged in liquid and there were no leaks/holes in the shell.A pin gauge was used to check the circumference of the fill tube tip and met requirement.The complaint was verified as the fill tube was disconnected from the slit valve upon receiving of the device; however, once reinserted the device performed as intended.

• 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: 9447412
• MDR Text Key: 183977539
• Report Number: 3006722112-2019-00192
• 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: 03/18/2020

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: 06/19/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF02990
• 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
• Patient Age: 44 YR
• Patient Weight: 85