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

Model Number 105-5055

Device Problem Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2013

Event Type  Injury  

Event Description

Embolization treatment of a meningioma in the mma (middle meningeal artery) in slightly tortuous anatomy.On (b)(6) 2013, the patient underwent treatment.The tip of the marathon catheter was steam shaped for 30 seconds prior to insertion.During the procedure, the physician could not visualize the distal radiopaque marker of the microcatheter under radiographic imaging while approaching the mma.For that reason, the physician removed the catheter from the patient and found the distal tip was missing.The missing tip was left inside the patient.No thrombus has been noted near the broken distal tip.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The catheter was returned for evaluation and it was broken at 171.5cm from the proximal end.The distal broken segment of the catheter remains in the patient.The broken end exhibited plastic deformation (stretching and necking) of the tubing material which indicates that the catheter broke when it was pulled with forces that exceeded the tensile strength of the tubing material.All catheters are 100% inspected for damages and irregularities prior to packaging.(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: 3581741
• MDR Text Key: 17927952
• Report Number: 2029214-2014-00034
• 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: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/09/2016
• Device Model Number: 105-5055
• Device Lot Number: 9732835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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
• Patient Outcome(s): Disability
• Patient Age: 59 YR