FDA Adverse Event
Other
Summary report: N
REVOLUTION
MDR report key: 1246415
·
Received November 20, 2008
Report
- Report Number
- 2939520-2008-00028
- Event Type
- Other
- Date Received
- November 20, 2008
- Date of Event
- October 10, 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
ALTHOUGH THERE WAS NO PT IMPACT ASSOCIATED WITH THIS INCIDENT, IF THE EVENT WERE TO REOCCUR, THERE COULD BE A POTENTIAL FOR INJURY. THIS REPORT IS BEING SENT AS A NOTIFICATION.
Description of Event or Problem · 1
THE SHAFT WAS KINKED IN A SHEATH WHEN THE CATHETER WAS ABOUT TO BE INSERTED IN A VESSEL, THEREFORE, IT WAS PULLED OUT OF THE SHEATH AND FOUND OUT THE MATERIAL OF SHAFT TUBE WAS TORN OFF, AND REMAINED INSIDE THE SHEATH. THERE WAS NO PT INJURY BECAUSE THE CATHETER WAS NOT INSERTED IN THE VESSEL. ANOTHER CATHETER WAS USED FOR THE PROCEDURE AND NO PROBLEM WAS REPORTED WITH IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVOLUTION | INTRAVASCULAR ULTRASOUND CATHETER | DQO | VOLCANO CORPORATION | 89000 | 035-02036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |