FDA Adverse Event
Malfunction
Summary report: N
BIB INTRAGASTRIC BALLOON SYSTEM
MDR report key: 19627292
·
Received June 27, 2024
Report
- Report Number
- 3005099803-2024-02999
- Event Type
- Malfunction
- Date Received
- June 27, 2024
- Date of Event
- June 4, 2024
- Report Date
- June 27, 2024
- Manufacturer
- APOLLO ENDOSURGERY
- Product Code
- LTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A150205 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE. IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABSENT OF TREATMENT.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ORBERA365 INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 THE PHYSICIAN REPORT THAT HE COULD NOT PASS THE BALLOON THROUGH THE PATIENTS ANATOMY DUE TO 4 CM HIATUS HERNIA. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 828659 | BIB INTRAGASTRIC BALLOON SYSTEM | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | APOLLO ENDOSURGERY | B-40800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |