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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY BIB INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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APOLLO ENDOSURGERY BIB INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Model Number B-40800
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure with a patient under anesthesia.
 
Event Description
It was reported to boston scientific corporation that a bib intragastric balloon system was used on an unknown procedure performed on (b)(6).2023.Upon removing from the packaging, the balloon was already broken.The procedure was not completed.There have been no patient complications reported as a result of this event.
 
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Brand Name
BIB INTRAGASTRIC BALLOON SYSTEM
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
APOLLO ENDOSURGERY
4221 freidrich ln., ste 195
austin TX 78744
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 Key18394750
MDR Text Key331501134
Report Number3005099803-2023-06894
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberB-40800
Device Lot NumberAF05384
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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