FDA Adverse Event
Malfunction
Summary report: N
SLEEK
MDR report key: 1241790
·
Received November 18, 2008
Report
- Report Number
- 9616666-2008-00008
- Event Type
- Malfunction
- Date Received
- November 18, 2008
- Report Date
- November 14, 2008
- Manufacturer
- CLEARSTREAM TECHNOLOGIES
- Product Code
- LIT
- PMA / PMN Number
- K072947
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS NOT AVAILABLE FOR RETURN, THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS FAILURE MODE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD FOR THE PRODUCT WAS REVIEWED AND NO ANOMALIES WERE OBSERVED. A HUB TORQUE TEST IS PERFORMED AS PART OF RELEASE TESTING FOR EACH LOT AND THE RESULTS FOR THIS TEST WERE WITHIN SPECIFICATION. IF THIS PRODUCT BECOMES AVAILABLE FOR RETURN OR FURTHER INFORMATION BECOMES AVAILABLE, WE WILL REOPEN THIS COMPLAINT AND INVESTIGATE FURTHER. THE COMPLAINT WILL ALSO BE TRACKED THROUGH OUR POST MARKET SURVEILLANCE PROCESS.
Description of Event or Problem · 1
(B) (4). WHILE TWISTING AND MANIPULATING THE CATHETER DURING PROCEDURE, THE SHAFT SNAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLEEK | PTA CATHETER | LIT | CLEARSTREAM TECHNOLOGIES | 4253015X | 50003135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |