MAUDE Adverse Event Report: COVIDIEN MARATHON; FLOW-DIRECTED MICROCATHETER

Model Number 105-5056

Device Problem Component Missing (2306)

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

Event Date 11/07/2014

Event Type  malfunction  

Event Description

Treatment of an avm (arteriovenous malformation).On (b)(6) 2014, the patient underwent embolization treatment.During the procedure, it was reported the tip of the marathon catheter was not visible under radiographic imaging.The microcatheter was removed from the patient and the marker band was missing.The missing marker band was not found inside the patient and another microcatheter was used to complete the procedure.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The device has been received, but the evaluation has not been completed yet.A follow-up report will be submitted once the evaluation is completed.

Manufacturer Narrative

The catheter was returned for evaluation with approximately 1cm of the distal tip and marker band were missing.It was confirmed that no segment or marker band were found in the patient.The broken end exhibited plastic deformation (stretching) of the tubing material indicating that the catheter broke when it was pulled exceeding the tensile strength of the tubing material.All device are 100% inspected for damages and irregularities during manufacture.(b)(4).

• Brand Name: MARATHON
• Type of Device: FLOW-DIRECTED MICROCATHETER
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4317956
• MDR Text Key: 21491761
• Report Number: 2029214-2014-00716
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2017
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: 9910913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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