MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Balloon was leaking at the catheter and was removed successfully.The surgery was completed with a competitor device.

Manufacturer Narrative

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 events of "obstruction of flow" are as follows: warnings and precautions: proper positioning of the placement catheter assembly and the orbera365¿ 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 orbera365¿ intragastric balloon system 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: patients must be advised that the igb is intended to be placed for 12 months maximally, at which point removal is required.Longer periods of igb placement increase the risk of igb deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when igbs are filled to a larger volume than indicated (greater than 700cc).Warning: when filling the igb during the placement procedure, avoid rapid fill rates as these will generate high pressure which can damage the igb valve or cause premature detachment of the igb from the tip of the placement catheter.Additional information: the device was returned.As it remains implanted.A device history record (dhr) review is required as there was one other similar complaint ((b)(4)) against this lot number, af04909 and allegation.

Manufacturer Narrative

Supplement # 1 medwatch submitted to the fda on 17/jan/2022.Additional information: a device history record (dhr) review is required as this complaint is a reportable event.The subject product met all specifications and requirements in effect at the time of manufacture.There was one other similar complaint against this lot number, af04909 and allegation.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 05/dec/2022.A deflated balloon with light blue coloration was returned.The fill tube was returned with the sheath on the fill tip.The fill tip was connected into the slit valve and the end of the balloon was clamped onto the pull force equipment, and it met minimum requirements.The fill tip pressure to inflate the balloon met the minimum requirements.An air leak test was performed on the device, and the shell slowly deflated due to small slits on the shell.The balloon was inflated a second time and submerged in water and there were no leaks at the valve.A pin gauge was used to check the circumference of the fill tube tip and it met specifications.The fill tip was checked for leaks using a pressure gage and there was a leak observed at the fill tip and tube connection.The complaint has been verified as there was a leak between the fill tip and connection of the fill tubing.Lab analysis was able to replicate the reported event of "fluid leak", as the fill tip leaks.The user effect of "fluid leak" is known and labeled possible adverse event.

• Brand Name: ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 15980999
• MDR Text Key: 308528721
• Report Number: 3006722112-2022-00128
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20240214(10)AF04909
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2024
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female