MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problems Difficult to Remove (1528); Short Fill (1575)

Patient Problem Failure of Implant (1924)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 20/nov/2020.The reporter noted that the device will not be returned for analysis.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 events of "failure to deploy" and "difficulty with fill tube" are as follows: warnings and precautions: proper positioning of the placement catheter assembly and the orbera® 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 orbera® 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 orbera® system valve or cause premature detachment.

Event Description

The balloon did not fill correctly with the proper fill volume, which then caused difficulties in removing the balloon as the instrument came with the grasper hooks crossed.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital 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 ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 10880094
• MDR Text Key: 217714788
• Report Number: 3006722112-2020-00114
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)2021-12-10(10)AF03407
• Combination Product (y/n): Y
• Reporter Country Code: CI
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

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: 12/10/2021
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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: 31 YR