MAUDE Adverse Event Report: HANSEN MEDICAL ARTISAN EXTEND CONTROL CATHETER

Model Number 12411

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pericardial Effusion (3271)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It was reported that artisan extend catheter does not want to deflect anterior in the left atrium.Biosense - webster smarttouch ablation catheter used when dr.(b)(6) pulled the artisan extend catheter back to the right atrium.There was no problem deflection the catheter anterior in the ra.During the procedure it was noticed small pericardial effusion, which did not require med intervention.

Manufacturer Narrative

The ifu lists pericardial effusion as a potential adverse event for the device.Investigation of the returned device did not find any issues with the device.All artisan extend catheters are tested for performance prior to release.In consideration of the lack of info provided by the site, hansen med is reporting this case.

• Brand Name: ARTISAN EXTEND CONTROL CATHETER
• Type of Device: ARTISAN EXTEND
• Manufacturer (Section D): HANSEN MEDICAL; mountain view CA
• Manufacturer Contact: ricken allen, sr dir, qa ; 800 e middlefield rd; mountain view, CA 94043 ; 6504042731
• MDR Report Key: 4239355
• MDR Text Key: 19764130
• Report Number: 3006026430-2014-00010
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K122275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 12411
• Device Lot Number: 14155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2013
• 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: BIOSENSE-WEBSTER SMARTTOUCH ABLATION CATHETER
• Patient Outcome(s): Other