ORBERA? INTRAGASTRIC BALLOON SYSTEM B-50000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for ORBERA? INTRAGASTRIC BALLOON SYSTEM B-50000 manufactured by Apollo Endosurgery, Inc..

Event Text Entries

[186735447] Initial medwatch sent to the fda. A review of the device labeling notes the following: the risk documentation for this device establishes the occurrence ranking for the reported event "inflation" as "remote", which is defined by apollo as. 02% -. 49% of complaints over units sold. A review for the intragastric balloon products for the failure mode "inflation" is performed during quarterly complaint analysis meetings (cam) and has demonstrated that global balloon inflation rate remains at "remote". Therefore, apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event, as referenced in the cam meeting slides. The current orbera? Intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain ", "vomiting", and "nausea" as follows: "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 symptoms. " "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. Abdominal or back pain, either steady or cyclic. "
Patient Sequence No: 1, Text Type: N, H10


[186735448] Reported as: "the patient complains of severe abdominal pain and vomiting. An x-ray was performed and noted balloon hyperinflation. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006722112-2020-00026
MDR Report Key9747069
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-24
Date of Report2020-01-28
Date of Event2019-12-07
Date Mfgr Received2020-01-28
Device Manufacturer Date2018-04-18
Date Added to Maude2020-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR. DAVID HOOPER
Manufacturer Street1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300
Manufacturer CityAUSTIN, TX
Manufacturer CountryUS
Manufacturer G1APOLLO ENDOSURGERY COSTA RICA, SRL
Manufacturer StreetCOYOL FREE ZONE BUILDING B 13.3
Manufacturer CityALAJUELA, CS
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORBERA? INTRAGASTRIC BALLOON SYSTEM
Generic NameINTRAGASTRIC BALLOON
Product CodeLTI
Date Received2020-02-24
Model NumberB-50000
Catalog NumberB-50000
Lot NumberAF01833
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAPOLLO ENDOSURGERY, INC.
Manufacturer Address1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN, TX US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-24

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