FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER NAVISTAR CATHETER
MDR report key: 1406799
·
Received June 23, 2009
Report
- Report Number
- 2029046-2009-00029
- Event Type
- Injury
- Date Received
- June 23, 2009
- Date of Event
- November 19, 2008
- Report Date
- May 28, 2009
- Manufacturer
- BIOSENSE WEBSTER, INC. (IRWINDALE)
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO BIOSENSE WEBSTER FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEFT EYE EMBOLUS IN 2008. THE EVENT WAS CONSIDERED AS POSSIBLY RELATED TO THE PROCEDURE. ALTHOUGH IT WAS INDICATED THAT THE EVENT RESULTED IN DISABILITY, NO INFORMATION WAS GIVEN REGARDING THE TYPE AND EXTENT OF THE DISABILITY. THE PATIENT HAD PREVIOUSLY HAD AN ABLATION PROCEDURE IN 2007 USING A 4MM NAVISTAR CATHETER (CATALOG NUMBER AND LOT NUMBER WERE NOT SPECIFIED). THE PATIENT ALSO UNDERWENT A RE-ABLATION PROCEDURE APPROX TWO MONTHS LATER, USING A 8MM NAVISTAR RMT CATHETER (CATALOG NUMBER AND LOT NUMBER WERE NOT SPECIFIED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER NAVISTAR CATHETER | DRF | BIOSENSE WEBSTER, INC. (IRWINDALE) | NAVISTAR TC | UNKNOWN_NAVISTA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |