FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER NAVISTAR THERMO-COOL
MDR report key: 1050184
·
Received May 23, 2008
Report
- Report Number
- 2029046-2008-00019
- Event Type
- Injury
- Date Received
- May 23, 2008
- Report Date
- May 22, 2008
- Manufacturer
- BIOSENSE WEBSTER, INC. (IRWINDALE)
- Product Code
- DRF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THERE WERE TWO SEPARATE OCCURRENCES TO THIS INJURY MENTIONED. EVENT RELATED TO ANOTHER DEVICES.
Description of Event or Problem · 1
INJURIES WERE REPORTED BASED ON A PRESENTATION RECEIVED DURING THE RECENT ACC (AMERICAN COLLEGE OF CARDIOLOGY) MEETING. THESE COMPLAINTS BROUGHT UP WERE LIKELY TO INVOLVE THE USE OF THE NAVISTAR THERMOCOOL CATHETER WITH THE HANSEN ROBOTIC SYSTEM. THE LABELING OF HANSEN ROBOTIC SYSTEM CONTRAINDICATES THE USE FOR ABLATION, THEREBY REPRESENTING OFF-LABEL USE. TWO OF THE COMPLICATIONS WERE CARDIAC POPS/TAMPONADES DURING ABLATIONS WHICH WERE SUCCESSFULLY TREATED WITH PERICARDIOCENTESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER NAVISTAR THERMO-COOL | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL | DRF | BIOSENSE WEBSTER, INC. (IRWINDALE) | NAVISTAR THERMO TC | UNKNOWN-NAVISTA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening| O |