MAUDE Adverse Event Report: APOLLO ENDOSURGERY OBERA

Model Number B-4800

Device Problems Entrapment of Device (1212); Material Puncture/Hole (1504)

Patient Problems Aspiration/Inhalation (1725); Vomiting (2144); Abdominal Distention (2601)

Event Date 08/11/2017

Event Type  Injury  

Event Description

Balloon inserted 1 week ago.Pt unable to tolerate balloon, had abdominal distention.Attempted gastric balloon removal, pt vomited on induction while attempting to intubate, bronchoscopy done to remove potential aspirate.Resumed egd/balloon removal 2600 cc of fluid aspirated from the stomach to enable of balloon.The balloon was visualized, it was noted to be wedged in the distal antrum, blocking the pylorus, explaining the pt's symptoms.Using an endoscope needle, the balloon was punctured.A catheter was advanced and 500 ml of balloon contents were aspirated.Once the balloon was completely free, a grasper was delivered and the edge of the balloon grasped.It was withdrawn from the stomach under direct vision up into the back of the throat.Balloon tore at the back of the throat.At this point, it was grasped with a kelly clamp and removed.The endoscope was then reintroduced.The remainder of the fluid was aspirated from the proximal fundus and all the air removed from the stomach.Pt extubated and recovered in pacu.Pt unable to maintain satisfactory oxygen saturation and sent for higher level of care for possible aspiration.

• Brand Name: OBERA
• Type of Device: OBERA
• Manufacturer (Section D): APOLLO ENDOSURGERY; austin TX 78746
• MDR Report Key: 6820524
• MDR Text Key: 83767111
• Report Number: MW5071786
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF 00470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 111