FDA Adverse Event
Malfunction
Summary report: N
BIOSENSE WEBSTER LASSO CATHETER
MDR report key: 951263
·
Received April 24, 2007
Report
- Report Number
- 2029046-2007-00055
- Event Type
- Malfunction
- Date Received
- April 24, 2007
- Date of Event
- March 28, 2007
- Report Date
- April 24, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- DRF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN PULLING OUT THE LASSO CATHETER THE DR DISCOVERED A PIECE OF MATERIAL WITH DIMENSIONS OF 2MM X 1.5MM IN THE LEFT VENTRICLE OF THE HEART. IT WAS INITIALLY THOUGH THAT A PIECE OF THE LASSO CATHETER HAD COME LOOSE, BUT UPON FURTHER INVESTIGATION THE MATERIAL WAS DETERMINED TO COME FROM THE GUIDEWIRE FROM THE SL DIAG SHEATH (NOT A BIOSENSE WEBSTER PRODUCT). NO PROBLEM WAS FOUND WITH ANY BIOSENSE WEBSTER PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER LASSO CATHETER | ELECTROPHYSIOLOGY CATHETER | DRF | BIOSENSE WEBSTER, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |