• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APOLLO ENDOSURGERY, INC ORBERA INTRAGASTRIC BALLOON SYSTEM Back to Search Results
Model Number B-50000
Device Problem Free or Unrestricted Flow (2945)
Patient Problem Vomiting (2144)
Event Date 12/21/2017
Event Type  malfunction  
Manufacturer Narrative
The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported event as follows: warnings and precautions: the physiological response of the patient to the presence of the orbera system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such.Complications: possible complications of the use of the orbera system include: - gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.- continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.
 
Event Description
Reported as: a patient had the orbera intragastric balloon placed, and after a period, "vomiting evolving rapidly and eda visualizing hyperinflation." the device was removed.
 
Manufacturer Narrative
Device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the balloon shell to be discolored, as it was light blue in appearance.Green particles were noted on the outer surface of the balloon shell and center patch.A sample fill tube was used for device testing.A valve test was performed, and when di water was injected into the valve, the flow of fluid was continuous and unobstructed.An air leak test was performed, and the balloon was noted to be leaking from the opening on the posterior of the shell and the opening on the radius of the shell.The opening on the posterior of the shell was located approximately 2.9 inches from the center patch, and the opening on the radius of the shell was located approximately 2.3 inches from the center patch.Under microscopic analysis, both openings were noted to have striated edges, consistent with damage from a surgical tool.The inner surface of the valve channel was noted to be discolored, as it was blue in appearance.Blue particulate matter was noted on the inner surface of the valve channel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORBERA 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
MDR Report Key7421370
MDR Text Key105399472
Report Number3006722112-2018-00103
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
PMA/PMN Number
P140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/20/2018
Device Model NumberB-50000
Device Catalogue NumberB-50000
Device Lot Number2922966
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight98
-
-