FDA Adverse Event
Other
Summary report: N
EAGLE EYE
MDR report key: 965031
·
Received December 14, 2007
Report
- Report Number
- 2939520-2007-00016
- Event Type
- Other
- Date Received
- December 14, 2007
- Date of Event
- November 20, 2007
- Report Date
- December 12, 2007
- Manufacturer
- VOLCANO CORPORATION
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RETURN, THE CATHETER WAS EVALUATED AND APPEARED TO HAVE BEEN BUILT PER SPECS. ALTHOUGH THE TIP DETACHMENT DID NOT OCCUR WHILE IN THE PT'S VESSEL AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO AN INJURY, A REPORT OF A CATHETER TIP DETACHMENT CAN HAVE SERIOUS CONSEQUENCES, THEREFORE, AN MDR REPORT IS BEING SUBMITTED AS NOTIFICATION.
Description of Event or Problem · 1
PROBLEMS WERE ENCOUNTERED WHILE TRYING TO ADVANCE THE IVUS CATHETER ALONG THE WIRE DUE TO DRY FLUID MATERIALS ON THE WIRE. WHEN REMOVING THE CATHETER FROM THE WIRE TO CLEAN THE WIRE, IT WAS NOTICED THAT THE DETACHED TIP WAS STILL ON THE WIRE. THIS HAPPENED OUTSIDE OF THE BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EAGLE EYE | IVUS CATHETER | DQO | VOLCANO CORPORATION | 85900 | 002 08254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |