FDA Adverse Event
Death
Summary report: N
SENSEI X
MDR report key: 4162461
·
Received October 8, 2014
Report
- Report Number
- 3006026430-2014-00008
- Event Type
- Death
- Date Received
- October 8, 2014
- Date of Event
- May 15, 2014
- Report Date
- October 8, 2014
- Manufacturer
- HANSEN MEDICAL, INC.
- Product Code
- DXX
- PMA / PMN Number
- K102168
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE IFU LISTS ESOPHAGEAL FISTULA AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE.
Description of Event or Problem · 1
PERSISTENT AF PT UNDERWENT AN ABLATION PROCEDURE USING AN RF ABLATION CATHETER, THE HANSEN ROBOTIC SYSTEM AND THE NAVX VELOCITY SYSTEMS. THE PHYSICIAN'S ABLATION STRATEGY INCLUDED ABLATION OF THE PVS AND ROOFLINE. THE PROCEDURE PROCEEDED UNEVENTFULLY. AN ATRIAL-ESOPHEAL FISTULA WAS IDENTIFIED IN THE POST PROCEDURE PERIOD. THE PHYSICIAN REPORTED THAT THE PT DIED WITH CAUSE OF DEATH FROM THE ATRIAL-ESOPHAGEAL FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631396 | SENSEI X | SENSEI X ROBOTIC CATHETER SYSTEM | DXX | HANSEN MEDICAL, INC. | 08257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |