MAUDE Adverse Event Report: HANSEN MEDICAL MAGELLAN ROBOTIC CATHETER 6FR; MAGELLAN CATHETER 6FR

Model Number 13607

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Thrombus (2101); Transient Ischemic Attack (2109); Confusion/ Disorientation (2553)

Event Date 10/22/2014

Event Type  Injury  

Event Description

It was reported that the doctor was doing a diagnostic angio of the left carotid.The catheter buckled as he was inserting into the carotid and had to restart.The doctor then regained access and did the angiogram.The robot was pulled out and it was noticed some confusion with the patient.Doctor went back in manually and called the neuro group to come up.It was found a small amount of clot in the brain and used tpa to dissolve the cloth.Doctor shah felt because he did not use heparin before he started and our catheter was up there longer then he thought it would be a clot may have formed.The patient recovered.

Manufacturer Narrative

There were no product malfunctions reported.Based on the physician's statement that the catheter may have contributed to the tia in this case as the catheter may have contacted aortic or carotid wall which may have dislodged thrombus/plaque.There are additional extenuating circumstances in this case i.E., no heparin that also likely contributed to the tia -transient ischemic attack.The ifu includes precautions to use anti-coagulant to avoid thrombus embolism.

• Brand Name: MAGELLAN ROBOTIC CATHETER 6FR
• Type of Device: MAGELLAN CATHETER 6FR
• Manufacturer (Section D): HANSEN MEDICAL; mountain view CA
• Manufacturer Contact: rick allen, sr.dir. ; 800 e. middlefield rd; mountain view, CA 94043 ; 6504042731
• MDR Report Key: 4255544
• MDR Text Key: 4988507
• Report Number: 3006026430-2014-00011
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133552
• 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: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 13607
• Device Lot Number: 20140529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 73 YR