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

Model Number	11814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	04/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product ifu lists aneurysm as a potential adverse event for the device.The adverse events listed in the ifu are similar to those expected with manual vascular catheter, guide wires, guiding sheaths, and guiding catheters.The catheter was unable to be evaluated because it was discarded.All magellan catheters are 100% inspected and evaluated prior to final release.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, (b)(6), has a known right internal carotid artery stenosis as seen on prior duplex ultrasound imaging and on prior ct angiogram of the neck, with symptoms of dizziness and bright light vision changes, went through right internal carotid artery stent placement, performed by dr.(b)(6) on (b)(6) 2016.A 9fr magellan catheter was inserted through l femoral artery and used to navigate and deliver treatment devices.Acculink stent was positioned and deployed successfully.The patient tolerated the procedure well and was discharged with intact neurologic function and palpable pedal pulses.On (b)(6) 2016, patient felt pain and swelling on his left groin.Patient was admitted to the hospital for further evaluation and care.Color and duplex doppler interrogation of the left high thigh was performed.The result showed sub-centimeter pseudo-aneurysm in the left groin.Patient was monitored in the hospital.On (b)(6) 2016, a limited color duplex sonography was performed again to evaluate the pseudo-aneurysm.The result showed that the pseudo-aneurysm was no longer visualized, and there was no evidence of residual pseudo-aneurysm.Patient was then discharged with no sequelae.

• Brand Name: MAGELLAN ROBOTIC CATHETER
• Common Device Name: MDR 9FR (80CM)
• Manufacturer (Section D): HANSEN MEDICAL; 800 east middlefield road; mountain view CA 94043
• MDR Report Key: 5695917
• Report Number: 3006026430-2016-00004
• Device Sequence Number: 88826
• Product Code: DRA
• UDI-Device Identifier: 00815671020031
• UDI-Public: 00815671020031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/03/2016

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: 05/31/2016
• Device Model Number: 11814
• Device Lot Number: 20150501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 06/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER VER 135
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR