FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER NAVISTAR RMT
MDR report key: 916866
·
Received September 21, 2007
Report
- Report Number
- 2029046-2007-00112
- Event Type
- Injury
- Date Received
- September 21, 2007
- Date of Event
- August 21, 2007
- Report Date
- September 21, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE SECTION ON PRECAUTIONS DURING CATHETER USE IN THE INSTRUCTION FOR USE STATES "DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER. CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE."
Description of Event or Problem · 1
THE CUSTOMER STATED THAT AFTER PERFORMING 18 RF APPLICATIONS REMOTELY, THE PHYSICIAN DECIDED TO TAKE OVER CATHETER CONTROL OF THE STEREOTAXIS SYSTEM TO COMPLETE THE PROCEDURE OF ATRIAL FIBRILLATION. IT WAS REPORTED THAT AFTER DELIVERING 2 MORE RF APPLICATIONS, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED AFTER WHICH PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR REPAIR OF CARDIAC PERFORATION. IT WAS FOUND THAT A PERFORATION WAS CAUSED OWING TO RF APPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER NAVISTAR RMT | ELECTROPHYSIOLOGY CATHETER | DRF | BIOSENSE WEBSTER, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Required Intervention |