FDA Adverse Event
Malfunction
Summary report: N
NAVISTAR THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
MDR report key: 1051320
·
Received May 23, 2008
Report
- Report Number
- 9673241-2008-00022
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 29, 2008
- Report Date
- April 29, 2008
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVAL IS IN PROGRESS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF PRODUCT EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP WAS SEPARATED FROM THE SHAFT OF THE THERMOCOOL CATHETER. THE PROBLEM WAS DISCOVERED BEFORE USE ON PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVISTAR THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL | OAD | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1197-18-S | 13359067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |