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

Model Number B-50000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to the fda.The current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "early removal" as follows: "warnings: patients must be advised that orbera¿ is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of balloon placement increase the risk of balloon 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 balloons are inflated to larger volumes (greater than 700cc).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

Awaiting information of description of event.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 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: 9447385
• MDR Text Key: 170294558
• Report Number: 3006722112-2019-00196
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF02546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2019
• 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