FDA Adverse Event
Death
Summary report: N
BIOSENSE WEBSTER NAVISTAR THERMOCOOL CATHETER
MDR report key: 830242
·
Received March 21, 2007
Report
- Report Number
- 2029046-2007-00034
- Event Type
- Death
- Date Received
- March 21, 2007
- Date of Event
- October 16, 2006
- Report Date
- March 19, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE VENTRICULAR TACHYCARDIA EVOLVED INTO VENTRICULAR FIBRILLATION. DEFIBRILLATION SHOCK WAS ADMINISTERED WHICH WAS FOLLOWED BY AN IRREVERSABLE CARDIOGENIC SHOCK. THE ADVERSE EVENT WAS REPORTED TO RESULT IN DEATH. IT WAS REPORTED BY THE PHYSICIAN THAT THE PT HAD SERIOUS LEFT VENTRICLE FAILURE BEFORE THE PROCEDURE. IT WAS REPORTED THAT BOTH BIOSENSE WEBSTER NAVISTAR THERMOCOOL AND LASSO CATHETERS WERE USED, BUT NO MODEL NUMBER OR SERIAL NUMBER WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER NAVISTAR THERMOCOOL CATHETER | ELECTROPHYSIOLOGY CATHETER | DRF | BIOSENSE WEBSTER, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death | BIOSENSE WEBSTER LASSO CATHETER WAS ALSO USED| DURING THE PROCEDURE |