FDA Adverse Event
Malfunction
Summary report: N
ULTRAFLEX COVERED ESOPHAGEAL STENT
MDR report key: 1172537
·
Received September 19, 2008
Report
- Report Number
- 3005099803-2008-04683
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- ESW
- PMA / PMN Number
- K995347
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO AN ESOPHAGEAL STENTING PROCEDURE, THE INNER PACKAGE OF THE ULTRAFLEX ESOPHAGEAL 10MM X 18MM STENT DELIVERY SYSTEM (SDS) HAD BEEN OPENED. THE DEVICE WAS NOT USED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS REPORTED AS "STABLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFLEX COVERED ESOPHAGEAL STENT | ESW PROSTHESIS, ESOPHAGEAL | ESW | BOSTON SCIENTIFIC | M00513100 | 11633104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |