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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Model Number B-50012
Device Problems Use of Device Problem (1670); Migration (4003)
Patient Problems Abdominal Pain (1685); Vomiting (2144); Obstruction/Occlusion (2422)
Event Date 01/03/2024
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an orbera balloon was implanted in the stomach on (b)(6) 2023, without any patient complications.On (b)(6) 2024, the patient was admitted to the hospital for observation for severe vomiting and abdominal pain.The patient then had an emergency gastroscopy, where it was found that the balloon caused an obstruction in the stomach.The balloon was explanted.There was no patient complication reported as a result of this event.Note: it was reported that methylene blue was used when filling the orbera balloon.However, according to the instructions for use (ifu) the igb is placed in the stomach and filled with sterile saline.
 
Manufacturer Narrative
Impact code f2202 captures the reportable event of endoscopic procedure.Impact code f08 captures the reportable event of hospitalization.Device codea010402 captures the reportable malfunction of device migration.Patient code e1002 captures the reportable event of pain.Patient code e2328 captures the reportable event of obstruction.
 
Event Description
It was reported to boston scientific corporation that an orbera balloon was implanted in the stomach on (b)(6) 2023, without any patient complications.On (b)(6) 2024, the patient was admitted to the hospital for observation for severe vomiting and abdominal pain.The patient then had an emergency gastroscopy, where it was found that the balloon caused an obstruction in the stomach.The balloon was explanted.The patient was discharged from the hospital a couple of days following the balloon removal.The patient had a follow up endoscopy 4-6 post op of the balloon removal.There was no patient complication reported as a result of this event.Note: it was reported that methylene blue was used when filling the orbera balloon.However, according to the instructions for use (ifu) the igb is placed in the stomach and filled with sterile saline.
 
Manufacturer Narrative
Impact code f2202 captures the reportable event of endoscopic procedure.Impact code f08 captures the reportable event of hospitalization.Device codea010402 captures the reportable malfunction of device migration.Patient code e1002 captures the reportable event of pain.Patient code e2328 captures the reportable event of obstruction.
 
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Brand Name
ORBERA365 INTRAGASTRIC BALLOON SYSTEM
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
APOLLO ENDOSURGERY
1120 s. capital of texas hwy
bldg 1 suite 300
austin TX 78746
Manufacturer (Section G)
APOLLO ENDOSURGERY COSTA RICA S.R.L
alajuela, 02
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18614772
MDR Text Key334214810
Report Number3005099803-2024-00169
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/21/2024
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? Yes
Device Operator Health Professional
Device Model NumberB-50012
Device Lot NumberAF05286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/05/2024
Initial Date FDA Received01/31/2024
Supplement Dates Manufacturer Received02/21/2024
Supplement Dates FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
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