FDA Adverse Event
Death
Summary report: N
BIOSENSE WEBSTER NAVISTAR THERMOCOOL CATHETER
MDR report key: 977570
·
Received January 11, 2008
Report
- Report Number
- 2029046-2008-00002
- Event Type
- Death
- Date Received
- January 11, 2008
- Date of Event
- December 13, 2007
- Report Date
- December 17, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC. (IRWINDALE)
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT 3 WEEKS AFTER A CASE, THE PT HAD DIED OF ESOPHAGEAL FISTULA. THE CASE WAS IN 2007. THE DOCTOR REPORTED THAT HE DID NOT FEEL THERE WAS ANYTHING WRONG WITH THE CATHETER AND THE CATHETER DID NOT CONTRIBUTE TO THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER NAVISTAR THERMOCOOL CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIA | DRF | BIOSENSE WEBSTER, INC. (IRWINDALE) | NAVISTAR THERMO TC | UNK_NAVISTA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Death |