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

Model Number B-50012

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Nausea (1970); Vomiting (2144)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the device was returned to the apollo device analysis laboratory on 06/july/2021.A deflated balloon with a significant amount of discoloration and a large slit on the shell was returned.Under microscopic analysis, the large hole on the shell has rounded edges and rolls inward.Due to the large hole, functional evaluation of the device could not be conducted.The complaint has been verified as it is uncertain how the large hole was created as the shell rolls inward which is not consistent with a puncture from a surgical instrument.

Event Description

Patient felt nausea and vomiting, balloon was deflated and removed successfully.

• Brand Name: ORBERA365 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 12160419
• MDR Text Key: 261732258
• Report Number: 3006722112-2021-00038
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20220716(10)AF03759
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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: 48 YR