FDA Adverse Event
Summary report: N
NAVI-STAR THERMO-COOL
MDR report key: 1100819
·
Received July 28, 2008
Report
- Report Number
- 1100819
- Date Received
- July 28, 2008
- Date of Event
- June 19, 2008
- Report Date
- July 28, 2008
- Manufacturer
- BIOSENSE WEBSTER
- Product Code
- OAD
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE TEMPERATURE READINGS FOR THE ABLATION CATHETER WERE TOO HIGH. THE CATHETER HANDLE WAS EXCHANGED FOR A DUPLICATE HANDLE AND THIS DID NOT RESOLVE THE ISSUE. THEN THE CATHETER WAS EXCHANGED FOR A DUPLICATE CATHETER AND THIS RESOLVED THE ISSUE. THERE WAS NOT ANY PATIENT HARM INVOLVED DUE TO THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVI-STAR THERMO-COOL | CATHETER, EP, ABLATION | OAD | BIOSENSE WEBSTER | * | 13391891 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |