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

Model Number 105-5055

Device Problem Hole In Material (1293)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Treatment of an avf (arteriovenous fistula).On (b)(6) 2014, the patient underwent embolization treatment.During the procedure, it was reported marathon microcatheter was advanced to the lesion and a hole was observed in the distal 1.5cm portion.Angiography could not be performed due to the hole in the microcatheter.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The marathon catheter was returned for evaluation and it was found ruptured at approximately 3.75cm from the distal end.The catheter appeared to have ruptured due to over-pressurization as a result of an occlusion (i.E.Solidified onyx / kink) within the catheter, resulting in pressures exceeding the limits of the catheter.All products are 100% inspected for damage and irregularities during manufacture.(b)(4).

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.(b)(4).

• Brand Name: MARATHON MICROCATHETER
• Type of Device: FLOW-DIRECTED MICROCATHETER
• 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: 4112833
• MDR Text Key: 4922715
• Report Number: 2029214-2014-00545
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2017
• Device Model Number: 105-5055
• Device Lot Number: 9871968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• 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