FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER NAVISTAR CATHETER
MDR report key: 716262
·
Received May 16, 2006
Report
- Report Number
- 9673241-2006-00026
- Event Type
- Injury
- Date Received
- May 16, 2006
- Date of Event
- May 11, 2006
- Report Date
- May 16, 2006
- Manufacturer
- BIOSENSE WEBSTER
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING MAPPING WITH NAVISTAR CATHETER, THE PT'S BLOOD PRESSURE DECREASED GRADULAAY. WHEN THE BLOOD PRESSURE REACHED 60'S, THE PHYSICIAN PERFORMED ECHOCARDIOGRAPHY AND FOUNS CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED IMMEDIATELY. THE BLOOD PRESSURE WENT BACK TO NORMAL LEVEL. THE PT STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER NAVISTAR CATHETER | ELECTROPHYSIOLOGY CATHETER | DRF | BIOSENSE WEBSTER | D-1183-07-S | 13056097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |