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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Device Problems Deflation Problem (1149); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an orbera intragastric balloon system deflated and migrated.On (b)(6) 2024, the patient reported the deflated and migrated of the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: device code a1401 is being used to capture the reportable event of deflation problem.Device code a010402 is being used to capture the reportable event of migration.
 
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Brand Name
ORBERA 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 Key19010422
MDR Text Key339006275
Report Number3005099803-2024-01319
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor
Reporter Occupation 505
Type of Report Initial
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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