FDA Adverse Event
Malfunction
Summary report: N
EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
MDR report key: 1213666
·
Received October 23, 2008
Report
- Report Number
- 2134265-2008-03106
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 27, 2008
- Report Date
- September 27, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- FGE
- PMA / PMN Number
- K021630
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, A BALLOON TEAR WAS NOTED. WHEN UNPACKING THE EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM, A SLIGHT BALLOON TEAR WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. THE DEVICE HAD NO CONTACT WITH THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC | NA | 11147879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |