FDA Adverse Event
Summary report: N
ULTRA ICE
MDR report key: 1101623
·
Received July 25, 2008
Report
- Report Number
- 1101623
- Date Received
- July 25, 2008
- Date of Event
- June 2, 2008
- Report Date
- July 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- ITX
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE IMAGE QUALITY OF THE ULTRASOUND CATHETER WAS POOR. THE CATHETER WAS EXCHANGED FOR ANOTHER ULTRASOUND CATHETER. THIS RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA ICE | CATHETER, MAPPING | ITX | BOSTON SCIENTIFIC | * | 11663840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |