ORBERA365 INTRAGASTRIC BALLOON SYSTEM
Report
- Report Number
- 3005099803-2024-00491
- Event Type
- Malfunction
- Date Received
- February 13, 2024
- Date of Event
- January 17, 2024
- Report Date
- April 16, 2024
- Manufacturer
- APOLLO ENDOSURGERY
- Product Code
- LTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMDF CODE A010402 MIGRATION, CAPTURES THE REPORTABLE EVENT OF BALLOON MIGRATION. IMDF CODE A1401 DEFLATION PROBLEM, CAPTURES THE REPORTABLE EVENT OF DEFLATION PROBLEM IMPACT CODE F2203 IMAGING REQUIRED HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED VIA GOOD FAITH EFFORTS ON MARCH 19, 2024.
BLOCK H6: IMDF CODE A010402 MIGRATION, CAPTURES THE REPORTABLE EVENT OF BALLOON MIGRATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA 365 BALLOON WAS IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, DURING THE PLANNED ENDOSCOPY FOR REMOVAL ON (B)(6) 2024, THE BALLOON WAS NO LONGER PRESENT. A COMPUTERIZED TOMOGRAPHY (CT) SCAN HAD BEEN PERFORMED ON THE PATIENT ON AN UNKNOWN DATE HOWEVER BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ACCESS TO THE RESULTS OF THIS TEST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA365 BALLOON WAS IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, DURING THE PLANNED ENDOSCOPY FOR REMOVAL ON (B)(6) 20254, THE BALLOON WAS NO LONGER PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 781004 | ORBERA365 INTRAGASTRIC BALLOON SYSTEM | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | APOLLO ENDOSURGERY | B-50012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |