FDA Adverse Event
Malfunction
Summary report: N
WALLFEX ENTERAL COLONIC STENT
MDR report key: 1111629
·
Received August 13, 2008
Report
- Report Number
- 3005099803-2008-02184
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 16, 2008
- Report Date
- July 16, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- MQR
- PMA / PMN Number
- K042065
- 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 PROCEDURE, SHEATH DAMAGE OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE COLON. THE WALLFLEX ENTERAL COLONIC 30/25X 12 STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. FOLLOWING DEPLOYMENT OF THE STENT, "THE PHYSICIAN INTENDED RE-POSITIONING" BUT "FOUND THE TIP OF SHEATH WAS SPLIT". THE DEVICE WAS REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 | WALLFEX ENTERAL COLONIC STENT | MQR | BOSTON SCIENTIFIC | M00565060 | 11484093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |