FDA Adverse Event
Injury
Summary report: N
ULTRAFLEX STENT SYSTEM
MDR report key: 632079
·
Received August 31, 2005
Report
- Report Number
- 6000050-2005-00035
- Event Type
- Injury
- Date Received
- August 31, 2005
- Date of Event
- August 18, 2005
- Report Date
- August 19, 2005
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- JCT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE COMPLAINANT HAS REPORTED THAT A PATIENT (AGE AND GENDER UNKNOWN) UNDER WENT A DILATATION OF A TRACHEAL TUMOR. THE PATIENT HADE AN ULTRAFLEX TRACHEAL STENT IN PLACE FOR ONE MONTH. THE PHYSICIAN ATTEMPTED TO DILATE THE TUMOR WITH A 10MM BALLOON. THE ATTEMPT TO DILATE THE TUMOR'S STRICTURE REPORTEDLY RESULTED IN THE STENT FRACTURING. THE FRACTURED STENT WAS REMOVED AND ANOTHER STENT WAS SUCCESSFULLY PLACED. THE PATIENT CONDITION IS NOTED TO BE FINE WITH NO REPORTED ILL EFFECTS AS A RESULT OF THE FRACTURED STENT OR REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFLEX STENT SYSTEM | METAL STENT | JCT | BOSTON SCIENTIFIC CORPORATION | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |