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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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APOLLO ENDOSURGERY, INC ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Model Number B-50012
Device Problems Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an orbera365 intragastric balloon system was used during an orbera balloon insertion procedure on (b)(6) 2023.During the procedure, the balloon was deforged when opened.The cover to the sheath was not enveloping the balloon proximally causing dilation at the balloon; making it unable to pass the esophageal sphincter.The procedure could not be completed at that time.
 
Manufacturer Narrative
H6: imdf code: f1001 absence of treatment is being used to capture the reportable issue or aborted/cancelled procedure.
 
Manufacturer Narrative
Block h6 additional information: imdf code f26, no health consequences or impact has been updated, and this is no longer a reportable event.Block g4: correction: ce mark only.
 
Event Description
It was reported to boston scientific corporation that an orbera365 intragastric balloon system was used during an orbera balloon insertion procedure on (b)(6) 2023.During the procedure, the balloon was deforged when opened.The cover to the sheath was not enveloping the balloon proximally causing dilation at the balloon; making it unable to pass the esophageal sphincter.The procedure could not be completed at that time.
 
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Brand Name
ORBERA365 INTRAGASTRIC BALLOON SYSTEM
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC
1120 s capital of texas hwy
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 Key18458758
MDR Text Key332222639
Report Number3005099803-2023-07068
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeMU
PMA/PMN Number
P140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2024
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
Device Model NumberB-50012
Device Lot NumberAF05382
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2023
Initial Date FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2023
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 Age35 YR
Patient SexFemale
Patient Weight96 KG
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