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

Model Number	11814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Numbness (2415)
Date of Event	12/22/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MCR 9FR (80CM)
• Manufacturer (Section D): HANSEN MEDICAL; 800 east middlefield road; mountain view CA 94043
• MDR Report Key: 5680189
• Report Number: 3006026430-2016-00003
• Device Sequence Number: 189887
• Product Code: DRA
• UDI-Device Identifier: 00815671020031
• UDI-Public: 00815671020031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2016

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2016
• Initial Report FDA Received Date: 05/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 86 YR