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

Model Number B-40800

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

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 "broken device" as follows: warnings and precautions: proper positioning of the placement catheter assembly and the bib¿ 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 bib¿ 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 bib¿ system valve or cause premature detachment.

Event Description

Health professional reported via product field notes (pfn), "the patient didn't notice any satiety and the balloon was split.Another balloon was placed.".

Manufacturer Narrative

Supplement #1-medwatch sent to the fda on 17/mar/2020.The reporter noted that the device will not be returned.Additional information: d4.

• 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: 9476687
• MDR Text Key: 183690079
• Report Number: 3006722112-2019-00198
• 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: 02/18/2020

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: 08/14/2020
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Device Lot Number: AF02091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR