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

Model Number 105-5055

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

Treatment of an avm (arteriovenous malformation) at the mma (middle meningeal artery).On (b)(6) 2014, the patient underwent embolization treatment.Prior to the treatment, the physician steam shaped the catheter tip and also shaped the guidewire tip.During the procedure, it was reported the tenrou (kaneka) guidewire perforated the marathon catheter while it was inserted through the microcatheter inside the patient's tortuous vasculature.The procedure was halted to replace the marathon catheter with another marathon catheter and the procedure was completed without issues.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The catheter was returned for evaluation without the tenrou guidewire used in the procedure.A puncture site was observed at 0.5cm from the distal tip.Evaluation could not determine the cause of the event.Eval: catheter puncture.(b)(4).

• 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: henry to ; 9775 toledo way; irvine, CA 92618 ; 9496801335
• MDR Report Key: 3637024
• MDR Text Key: 4203653
• Report Number: 2029214-2014-00096
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/02/2016
• Device Model Number: 105-5055
• Device Lot Number: 9770034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• 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