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

Model Number 105-5055

Device Problems Component Missing (2306); Malposition of Device (2616)

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

Event Date 05/08/2014

Event Type  malfunction  

Event Description

Embolization of a cerebral arteriovenous fistula.On (b)(6) 2014, the patient underwent embolization treatment.During the procedure, it was reported the marker band of the marathon catheter was missing when the catheter was removed from the patient.The marker band was found inside the rotating hemostatic valve.It was noted that the marker band was seen as the catheter was navigated to the lesion and there was no resistance felt a the catheter was removed from the rotating hemostatic valve.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

Approximately 0.6cm of the distal tip and marker band were returned for evaluation as the rest of the catheter was discarded.The evaluation showed that the broken end exhibited plastic deformation (stretching) of the tubing material indicating that the catheter broke as it was pulled with a force exceeding the tensile strength of the tubing material.(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: 3849734
• MDR Text Key: 4615413
• Report Number: 2029214-2014-00314
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• 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: 05/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• 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