MAUDE Adverse Event Report: EV3 NEUROVASCULAR MARATHON MICRO CATHETER; FLOW-DIRECTED MICRO CATHETER

Model Number 105-5055

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 08/05/2014

Event Type  Injury  

Event Description

Treatment of a posterior avm (arteriovenous malformation).On (b)(6) 2014, the patient underwent onyx embolization treatment.After the onyx injection, it was reported the onyx was observed to be leaking from a tiny hole in the marathon catheter into the vertebral artery.Since the onyx was left suspended in the vertebral artery and presented a stroke risk, the vessel had to be sacrificed.Same event as mdr# 2029214-2014-00509.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation as it was kept at the site.

• Brand Name: MARATHON MICRO CATHETER
• Type of Device: FLOW-DIRECTED MICRO CATHETER
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4046814
• MDR Text Key: 4736153
• Report Number: 2029214-2014-00508
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/17/2017
• Device Model Number: 105-5055
• Device Lot Number: 9865303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2014
• 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