MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number B-4800

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/11/2018

Event Type  malfunction  

Event Description

Patient undergoing placement of an orbera intragastric balloon.Per staff report, the physician inserted and placed the balloon.The balloon is encased in a protective sheath attached to a guide wire to help with inserting the balloon through the esophagus into the stomach.Following placement of the balloon, the catheter was removed.The sheath was noted to have detached from the catheter and was still inside the patient.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 7676980
• MDR Text Key: 113693089
• Report Number: 7676980
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 97