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 Perforation of Esophagus (2399)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to the fda.The device was returned to the apollo device analysis laboratory on 10/feb/2020.Analysis of the device is ongoing.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 events of "difficulty with fill tube" and "esophageal perforation" as follows: the physiological response of the patient to the presence of bib¿ 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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 6 months of placement.Clinical data does not exist to support use of an individual bib¿ beyond 6 months.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the bib¿ intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications - possible complications of the use of bib¿ include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Possible complications of routine endoscopy & sedation - potential risks associated with upper endoscopic procedures include, but are not limited to: abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach, and aspiration pneumonia.The risk increases if additional procedures are performed.Warnings: proper positioning of the placement catheter assembly and the bib¿ balloon within the stomach (using measured distance from the incisors via the insertion tube markings) is necessary to allow for proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.Failure to confirm proper positioning may cause injury to the esophagus, duodenum, or pylorus.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.

Event Description

Reported as: disconnected from filling tube.Patient presented distal esophagus tear.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 09/mar/2020.Additional information: d4, h3, h6, h10.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 10/feb/2020.A partially deployed balloon was returned without the fill tube.The sheath is still present on half of the shell and there is blue liquid in the deployed portion of the shell.As the device was not received with the fill tube, a sample fill tube was used for device testing.A syringe was used to push air into the balloon and the pressure met minimum requirements to inflate.There were small slits observed on the shell from surgical removal instruments.Per engineering, without the fill tube being returned, all essential testing was performed and no discrepancies were observed.

• 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
• MDR Report Key: 9747065
• MDR Text Key: 182191435
• Report Number: 3006722112-2020-00022
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Device Lot Number: AF03017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95