FDA Adverse Event
Other
Summary report: N
REVOLUTION
MDR report key: 972204
·
Received December 21, 2007
Report
- Report Number
- 2939520-2007-00018
- Event Type
- Other
- Date Received
- December 21, 2007
- Date of Event
- October 2, 2007
- Report Date
- December 20, 2007
- Manufacturer
- VOLCANO CORPORATION
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A TEAM CONSISTING OF MFG ENGINEERING, R&D, AND QA ANALYZED THE RETURNED CATHETER. IT WAS SUSPECTED THAT THE PROXIMAL SHAFT WAS KINKED WHILE THE CATHETER WAS BEING FED INTO THE INTRODUCER. THE CATHETER APPEARED TO HAVE BEEN MANUFACTURED TO SPECIFICATION. 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 SEPARATED WHEN THE CATHETER WAS INSERTED INTO THE Y ADAPTOR. THERE WAS NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVOLUTION | IVUS CATHETER | DQO | VOLCANO CORPORATION | 89000 | 035 01338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |