FDA Adverse Event
Malfunction
Summary report: N
WALLFLEX DUODENAL STENT
MDR report key: 1161323
·
Received September 11, 2008
Report
- Report Number
- 3005099803-2008-04483
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 14, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- MUM
- PMA / PMN Number
- K062750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED GASTRO-INTESTINAL (GI) PROCEDURE, THE STENT FAILED TO DEPLOY. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE DUODENUM. THE 22 X 6 WALLFLEX ENTERAL DUODENAL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, HOWEVER, THE STENT WAS UNABLE TO BE DEPLOYED AND WAS REMOVED FROM THE PT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLFLEX DUODENAL STENT | MUM | BOSTON SCIENTIFIC | M00565010 | 9507836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |