|
Model Number B-50000 |
Device Problem
Free or Unrestricted Flow (2945)
|
Patient Problem
Vomiting (2144)
|
Event Date 12/20/2017 |
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 "a patient presented symptoms of vomiting progressively evolving.X-ray was performed and confirmed hiperinflation of intragastric balloon." the device was removed.
|
|
Manufacturer Narrative
|
Supplement #1 - medwatch sent to fda on 02-jul-2018.Device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the balloon shell to be discolored, as it was blue and green in appearance.Green particulate matter was noted to be covering approximately 80% of the balloon shell.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 eight separate openings.Seven of the eight openings were observed on the anterior portion of the balloon, and one opening was located on the radius.Under microscopic analysis, all openings were noted to have striated edges, consistent with damage from a surgical tool.Material degradation was noted to be covering approximately 70% of the balloon shell.Black particulate matter was noted on the inner surface of the valve channel.
|
|
Search Alerts/Recalls
|
|
|