FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER LASSO CATHETER
MDR report key: 801914
·
Received January 5, 2007
Report
- Report Number
- 2029046-2007-00001
- Event Type
- Injury
- Date Received
- January 5, 2007
- Date of Event
- April 12, 2006
- Report Date
- January 5, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- LPB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SECTION ON PRECAUTIONS IN THE INSTRUCTION FOR USE STATES "CAREFUL MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE."
Description of Event or Problem · 1
IT WAS REPORTED THAT A TAMPONADE WAS DISCOVERED DURING LEFT PULMONARY VEIN ABLATION. MEDICAL INTERVENTION WAS ADMINISTERED, BUT NOT SPECIFIED. IT WAS REPORTED THAT THE EVENT WAS PROCEDURE RELATED AND THE PT REQUIRED PROLONGED HOSPITALIZATION. PRODUCT INVOLVED WAS REPORTED TO BE A BIOSENSE WEBSTER LASSO CATHETER, BUT SPECIFIC MODEL NUMBER AND SERIAL NUMBER WERE UNAVAILABLE. PROGNOSIS OF THE PT WAS REPORTED TO BE EXCELLENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER LASSO CATHETER | ELECTROPHYSIOLOGY CATHETER | LPB | BIOSENSE WEBSTER, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Life Threatening |