FDA Adverse Event
Malfunction
Summary report: N
NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
MDR report key: 2061306
·
Received April 18, 2011
Report
- Report Number
- 2029046-2011-00030
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 25, 2011
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE END OF THE PROCEDURE AFTER RETRIEVING THE CATHETER FROM THE PATIENT'S BODY, A THROMBUS FORMATION WAS SEEN AT THE TIP OF THE CATHETER. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | OAD | BIOSENSE WEBSTER, INC (IRWINDALE) | NAVISTAR THERMO TC | UNKNOWN_NAVISTAR TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |