MAUDE Adverse Event Report: APOLLO ENDOSURGERY BIB INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number B-40800

Device Problems Inflation Problem (1310); Use of Device Problem (1670)

Patient Problems Inflammation (1932); Nausea (1970); Vomiting (2144); Paresthesia (4421)

Event Date 08/11/2023

Event Type  Injury  

Event Description

It was reported that an orbera bib intragastric balloon system was implanted into the patient on (b)(6) 2023.The patient experienced nausea, vomiting, and tingling in his hands and was hospitalized.Upon hospitalization, the patient presented with hypokalemia and esophagitis, and a ct scan was done.The orbera balloon was explanted on (b)(6) 2023.During explantation of the orbera bib intragastric balloon system, the balloon was found to be hyperinflated.The procedure was completed and there were no other patient complications as a result of this event.No other treatment was required for this event.The device has not been returned.

Manufacturer Narrative

Block h6: patient code e1032 is being used to capture the reportable issue of vomiting.Patient code e1020 is being used to capture the reportable issue of nausea.Patient code e120206 is being used to capture the reportable issue of hypokalemia.Patient code e013403 is being used to capture the reportable issue of paresthesia.Patient code e2326 is being used to capture the reportable issue of inflammation.Impact code f08 is being used to capture the reportable issue of hospitalization or prolonged hospitalization.Impact code f23 is being used to capture the reportable issue of unexpected medical intervention.Impact code f2203 is being used to capture the reportable issue of imaging required.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.

Manufacturer Narrative

Block h6: patient code e1032 is being used to capture the reportable issue of vomiting.Patient code e1020 is being used to capture the reportable issue of nausea.Patient code e120206 is being used to capture the reportable issue of hypokalemia.Patient code e013403 is being used to capture the reportable issue of paresthesia.Patient code e2326 is being used to capture the reportable issue of inflammation.Impact code f08 is being used to capture the reportable issue of hospitalization or prolonged hospitalization.Impact code f23 is being used to capture the reportable issue of unexpected medical intervention.Impact code f2203 is being used to capture the reportable issue of imaging required impact code f2202 is being used to capture the reportable issue of endoscopic procedure.

Event Description

It was reported that a bib intragastric balloon system was implanted into the patient on (b)(6) 2023.On (b)(6) 2023, the patient experienced nausea, vomiting, and tingling in his hands and was hospitalized.Upon hospitalization, the patient presented with hypokalemia and esophagitis, and a ct scan was done and it was found that the balloon was hyerinflated.It was reported that there was additional treatment.The balloon was explanted on (b)(6) 2023.Another balloon was implanted without any complications.No further information has been obtained despite good faith efforts.

• 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 Key: 18395073
• MDR Text Key: 331341247
• Report Number: 3005099803-2023-06813
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-40800
• Device Lot Number: AF05125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 87 KG