MAUDE Adverse Event Report: HANSEN MEDICAL MAGELLAN ROBOTIC CATHETER; MCR 9FR (80CM)

Model Number 11814

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Numbness (2415)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

The catheter was unable to be evaluated because it was discarded.All magellan catheters are 100% inspected and evaluated prior to final release.The physician did not allege that the device may have caused or contributed to the temporary event.From the information provided by the physician and hospital, hansen medical is unable to determine the cause of the event.

Event Description

Patient presented with symptomatic right carotid artery stenosis.Had angiography on right common carotid artery on (b)(6) 2015.A magellan catheter was used to navigate from access site (left femoral artery) to the right common carotid artery.Angiography was completed successfully and followed with surgical procedure on right carotid endarterectomy (right cea) the next day (b)(6) 2015.The guidewires and diagnostic catheters used during the procedures were not manufactured or provided by hansen medical.On (b)(6) 2015, patient was admitted to the hospital with complaint of bilateral blurry vision and left hand numbness which lasted 5-10 minutes.Magnetic resonance imaging (mri) showed no evidence of acute cerebral ischemia.Computed tomography angiography (cta) of neck showed no thrombus at right cea operative site.On (b)(6) 2015 patient was consulted to neurology.Neurology consultation noted the bilateral blurry vision and left hand numbness complaints were not conclusive as a transient ischemic attack (tia).Patient was discharged on (b)(6) 2016.

• Brand Name: MAGELLAN ROBOTIC CATHETER
• Type of Device: MCR 9FR (80CM)
• Manufacturer (Section D): HANSEN MEDICAL; 800 east middlefield road; mountain view CA 94043
• Manufacturer (Section G): HANSEN MEDICAL; 800 east middlefield road; mountain view CA 94043
• Manufacturer Contact: monica nachbar ; 800 east middlefield road; mountain view, CA 94043 ; 6504045800
• MDR Report Key: 5680189
• MDR Text Key: 45957599
• Report Number: 3006026430-2016-00003
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00815671020031
• UDI-Public: 00815671020031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2016
• Device Model Number: 11814
• Device Catalogue Number: MC9F80
• Device Lot Number: 20150619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR