FDA Adverse Event
Injury
Summary report: N
NAVISTAR/CELSIUS THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE
MDR report key: 1192803
·
Received October 8, 2008
Report
- Report Number
- 9673241-2008-00040
- Event Type
- Injury
- Date Received
- October 8, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 15, 2008
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUCTION FOR USE CONTRAINDICATES USE OF THE CATHETER IN PATIENT WITH PROSTHETIC VALVE.
Description of Event or Problem · 1
EVENT OCCURRED DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE. RETROGRADE AORTIC ACCESS WITH AN IRRIGATED TIP CATHETER. PATIENT HAD A METALLIC MITRAL BIVALVE. LEFT VENTRICULE WAS BEING MAPPED WHEN, UNINTENTIONALLY, THE CATHETER GOT TRAPPED INSIDE THE VALVE. IT IS WORTHWHILE NOTING THAT THE LEFT ATRIUM MAPPING WAS NOT THE TARGET OF THE PROCEDURE (IN FACT, WHEN THE INCIDENCE TOOK PLACE, THE AIM WAS TO PERFORM THE LEFT VENTRICLE MAPPING). ATTEMPT TO REMOVE THE CATHETER WAS NOT SUCCESSFUL. THEREFORE THE CATHETER HAD TO BE REMOVED SURGICALLY. THE PATIENT WAS STABLE AND RECOVERING FROM THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVISTAR/CELSIUS THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A | OAD | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1197-17-S | 13349765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| L| R |