FDA Adverse Event
Malfunction
Summary report: N
ADVANIX PANCREATIC STENT
MDR report key: 20152829
·
Received September 5, 2024
Report
- Report Number
- 3005099803-2024-04273
- Event Type
- Malfunction
- Date Received
- September 5, 2024
- Date of Event
- August 14, 2024
- Report Date
- September 5, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729856856
- PMA / PMN Number
- K133700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 COMPONENT MISSING.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT A PANCREATIC STONE DURING A PANCREATIC STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE ENDOSCOPIC MARKER ON THE DUODENAL SIDE OF THE STENT WAS DIFFICULT TO VIEW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1887559 | ADVANIX PANCREATIC STENT | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00537260 | 0033403814 | 08714729856856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |