MAUDE Adverse Event Report: HANSEN MEDICAL, INC. ARTISAN EXTEND ; NAVIGATION CATHETER, STEERABLE

Model Number 04454

Device Problem Insufficient Information (3190)

Patient Problems Occlusion (1984); Cardiac Tamponade (2226)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

There were no product malfunctions reported.The artisan extend navigation catheter performed according to the approved instruction for use.All artisan extend catheters are tested for performance prior to release.The artisan extend catheter does not provide energy for ablation.Based on the info and statement by the physician, the device was an "unk" contributor to the events, hansen medical is reporting this case.Device was discarded at the time of the procedure and was not retrievable for investigation.The pt recovered the following day.

Event Description

The physician completed a procedure uneventfully using the sensei and artisan extend catheter.For the procedure, the physician placed 4 sheaths into the pt's right vein (14f, 11f, 10f, 7f).While in recovery, approximately 1 hour post procedure the pt developed a right groin/leg issue.A vascular surgeon was consulted.He determined the pt developed a total occlusion of the superficial femoral artery (sfa) and decided to intervene to remove the blockage.While administering anesthesia for the vascular intervention, the anesthesiologist noticed the pt was more difficult to manage and a transesophageal echocardiography (tee) was performed.The pt developed cardiac tamponade.The physician was called and performed a pericardiocentesis and drained approximately 450cc.The tamponade occurred approximately 3 hours post ep procedure.No effusion was seen on ice at the completion of the ep procedure.According to the physician, the pt is doing much better today.

• Brand Name: ARTISAN EXTEND
• Type of Device: NAVIGATION CATHETER, STEERABLE
• Manufacturer (Section D): HANSEN MEDICAL, INC.; mountain view CA
• Manufacturer Contact: meliha mulalic, sr. qa mgr ; 800 e. middlefield rd.; mountain view, CA 94043 ; 6504045977
• MDR Report Key: 4994525
• MDR Text Key: 22874795
• Report Number: 3006026430-2015-00003
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABLATION CATHETER - TACTICATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR