FDA Adverse Event
Malfunction
Summary report: N
SMARTWIRE II
MDR report key: 1171625
·
Received September 12, 2008
Report
- Report Number
- 1171625
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 11, 2008
- Report Date
- September 9, 2008
- Manufacturer
- VOLCANO THERAPEUTICS, INC
- Product Code
- OBJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
CATHETER (DISTAL PRESSURE AND RATIO) DID NOT READ ON TO THE MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTWIRE II | GUIDEWIRE, INTRAVASCULAR ULTRASOUND, PRESSURE SENSING | OBJ | VOLCANO THERAPEUTICS, INC | 6603 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |