FDA Adverse Event
Malfunction
Summary report: N
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
MDR report key: 1026152
·
Received April 7, 2008
Report
- Report Number
- 3005099803-2008-00331
- Event Type
- Malfunction
- Date Received
- April 7, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 7, 2008
- Manufacturer
- BOSTON SCIENTIFIC IRELAND, LTD.
- Product Code
- JCT
- PMA / PMN Number
- K012752
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE FEBRUARY 2008 15-MONTH ULTRAFLEX TRACHEOBRONCHIAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.
Description of Event or Problem · 1
NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO MALFUNCTIONS OCCURRING DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT #3005099803-2008-00332 FOR EVENT DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM | JCT | BOSTON SCIENTIFIC IRELAND, LTD. | M00569920 | 9388195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |