FDA Adverse Event
Injury
Summary report: N
ARTISAN
MDR report key: 952110
·
Received November 21, 2007
Report
- Report Number
- 3006026430-2007-00002
- Event Type
- Injury
- Date Received
- November 21, 2007
- Date of Event
- October 22, 2007
- Report Date
- November 21, 2007
- Manufacturer
- HANSEN MEDICAL, INC.
- Product Code
- DRA
- PMA / PMN Number
- K052480
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AFTER A MANUAL TRANSEPTAL PUNCTURE, THE ARTISAN CATHETER APPEARED TO BE ACROSS THE SEPTUM, BUT MANIPULATIONS OF THE DEVICE WERE CONSISTENT WITH THE DEVICE BEING CONSTRAINED. WHEN THE DEVICE WAS RETRACTED THE PT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS NOTED ON ICE. PERICARDIOCENTESIS WAS PERFORMED AND THE PT STABILIZED WITHOUT ONSET OF TAMPONADE. THERE WAS NO MALFUNCTION OF THE DEVICE AND THE EVENT WAS DETERMINED TO BE PROCEDURE RELATED. THE PT WAS TRANSFERRED TO THE CCU IN STABLE CONDITION. THE IFU LISTS PERICARDIAL EFFUSION AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTISAN | CATHETER, STEERABLE | DRA | HANSEN MEDICAL, INC. | 04454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Life Threatening |