FDA Adverse Event
Injury
Summary report: N
VISIONS PV-82
MDR report key: 1058365
·
Received January 22, 2008
Report
- Report Number
- 1058365
- Event Type
- Injury
- Date Received
- January 22, 2008
- Date of Event
- November 13, 2007
- Report Date
- November 14, 2007
- Manufacturer
- VOLCANO CORP
- Product Code
- GCJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE INTRAVASCULAR ULTRASOUND IMAGING CATHETER TIP DISLODGED AND CANNOT BE LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIONS PV-82 | NONE | GCJ | VOLCANO CORP | 88900 | 00401549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |