FDA Adverse Event
Other
Summary report: N
LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER
MDR report key: 647009
·
Received November 17, 2005
Report
- Report Number
- 2029046-2005-00107
- Event Type
- Other
- Date Received
- November 17, 2005
- Date of Event
- October 17, 2005
- Report Date
- October 18, 2005
- Manufacturer
- BIOSENSE WEBSTER
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE LASSO CATHETER BECAME STUCK IN THE SMALL BRANCH OF PULMONARY VEIN. THE PHYSICIAN WAS ABLE TO MANIPULATE THE CATHETER AND REMOVE IT WITHOUT SURGERY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER | DEFLECTABLE MAPPING CATHETER | DRF | BIOSENSE WEBSTER | D7-L10-20-RT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Life Threatening| R |