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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 Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Event Description
Note: this pertains to two bib intragastric balloons.It was reported to boston scientific corporation that a bib intragastric balloon system was going to be implanted on (b)(6) 2024.During, preparation of the balloon; it was discovered that the balloon was found with the casing broken.Another of the same balloon was opened, and the same issue was noticed.The case was then cancelled.
 
Manufacturer Narrative
Block 6: imdrf code f1001 captures the reportable event of absence of treatment.
 
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Brand Name
BIB 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 Key18934750
MDR Text Key338084366
Report Number3005099803-2024-01161
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
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 03/19/2024
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-40800
Device Lot NumberAF05449
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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