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 bib¿ system intragastric balloon directions for use (dfu) addresses the known and anticipated potential event of "difficulty with fill tube" as follows: "precautions: if difficulty with the bib¿ 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 bib¿ valve or cause premature detachment of the balloon from the placement catheter." "bib¿ 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 bib¿ 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), "catheter got autonomously detached once inserted into stomach.".

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 19/dec/2019 the device was returned to the apollo device analysis laboratory on (b)(6) 2019.Analysis of the device is ongoing.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 20/jan/2020.Additional information: h3, h6, h10.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 25/nov/2019.The balloon was returned with blue liquid present and the fill tube has been disconnected from the valve.View of the fill tube shows it's bent, and the sheath is present on the balloon.Fill tube diameter fails specification.This indicates that the fill tip got bent during fill tube assembly.Angled fill tip to valve connection is more prone to dislodgement if joint is flexed against the bend section.Fill-tip to valve retention force and valve opening pressure meets specifications.

• 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: 9447386
• MDR Text Key: 183976725
• Report Number: 3006722112-2019-00190
• 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: 01/17/2019

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: 11/25/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1