FDA Adverse Event
Other
Summary report: N
REVOLUTION CATHETER
MDR report key: 1211499
·
Received October 23, 2008
Report
- Report Number
- 2939520-2008-00025
- Event Type
- Other
- Date Received
- October 23, 2008
- Date of Event
- September 22, 2008
- Report Date
- October 24, 2008
- Manufacturer
- VOLCANO CORPORATION
- Product Code
- DQO
- PMA / PMN Number
- K080891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WAS NOT RETURNED TO THE MANUFACTURE FOR ANALYSIS. IN THE PAST, A SEVERELY KINKED GUIDE WIRE WAS FOUND TO BE ATTRIBUTED TO A FAILURE MODE SUCH AS THIS. SINCE THE GUIDE WIRE AND CATHETER WERE NOT RETURNED, A FINAL DISPOSITION FOR ROOT CAUSE CAN NOT BE DETERMINED. THIS REPORT IS BEING SENT AS A NOTIFICATION.
Description of Event or Problem · 1
RESISTANCE WAS FELT DURING THE THIRD PULL-BACK OF A PROCEDURE. THE LUMEN OF THE CATHETER WAS FOUND TO HAVE A BUR WHEN IT WAS REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVOLUTION CATHETER | IVUS CATHETER | DQO | VOLCANO CORPORATION | 89000 | 035-01950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |