FDA Adverse Event
Malfunction
Summary report: N
ADVANIX BILIARY
MDR report key: 18095195
·
Received November 8, 2023
Report
- Report Number
- 3005099803-2023-05987
- Event Type
- Malfunction
- Date Received
- November 8, 2023
- Date of Event
- October 18, 2023
- Report Date
- November 8, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729787327
- PMA / PMN Number
- K101314
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A020602 CAPTURES THE REPORTABLE EVENT OF RO MARKER BAND MISSING.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE RO MARKER BAND WAS MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1237875 | ADVANIX BILIARY | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00534230 | 0031310533 | 08714729787327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |