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

Model Number B-50012

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.A review of the device labeling could not be conducted as there is insufficient information regarding the event.

Event Description

No information provided by the reporter.

Manufacturer Narrative

Device evaluation summary: the device was returned to the apollo device analysis laboratory on 21/oct/2019.A deployed balloon was received only for evaluation.The balloon was noted to be discolored, as the shell was green in appearance, and the center patch was yellow in appearance.One large tear was noted on the posterior portion of the balloon shell, opposite the center patch.The tear was noted to be covering approximately 25% of the balloon shell.Yellow and brown particles were observed on the slit valve through the tear on the balloon shell.Three openings were noted on the radius of the balloon shell.An air leak test was not feasible, as the device had a large tear covering approximately 25% of the balloon shell.

Manufacturer Narrative

Device evaluation summary: the device was returned to the apollo device analysis laboratory on 12/nov/2019.A visual examination was performed on the device, and noted a discolored balloon with a large hole present.There were no other components returned with the device.Due to the large hole present in the shell, functional evaluation could not be conducted.Observation of the hole shows smooth edges with the edges rolling inward with significant discoloration present on the balloon shell.

• Brand Name: ORBERA365® INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• 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: 9476695
• MDR Text Key: 173910294
• Report Number: 3006722112-2019-00186
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention