MAUDE Adverse Event Report: HANSEN MEDICAL INC. MAGELLAN ROBOTIC CATHETER; MRC 6FR 1.1 LONG CATHETER

Model Number 22658

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Peripheral Vascular Disease (2002)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

The product ifu lists perforation 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.Catheter discarded by site.

Event Description

Patient presented with a chronic total occlusion (cto) of the superficial femoral artery-r and profunda-femoral-r artery.Patient had stenting treatment of the sfa and an angioplasty of the profunda artery performed through the robotic catheter.Guide wires, balloons and stents used during the procedure were not manufactured or provided by hansen medical.During the procedure the patient experienced a peripheral perforation.Bleeding was discovered after surgery while patient was in the post-anesthesia care unit (pacu).Patient complained of right thigh pain.Assessment revealed tight, swollen thigh.Bedside ultrasound was used to confirm bleeding.Site was unable to determine the specific location of the perforation.Treated with ace wrap compression, intravenous fluids, and blood transfusion.Bleeding resolved before resident evaluated the patient the next day.The event resolved with no sequelae.On (b)(6) 2015, patient had post procedure follow-up with no event.

• Brand Name: MAGELLAN ROBOTIC CATHETER
• Type of Device: MRC 6FR 1.1 LONG CATHETER
• Manufacturer (Section D): HANSEN MEDICAL INC.; 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: 5608900
• MDR Text Key: 43668698
• Report Number: 3006026430-2016-00002
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: 22658
• Device Catalogue Number: MCF6F95
• Device Lot Number: 20150407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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
• Treatment: COOK MEDICAL BALLOON
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR