MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

H3: the marathon micro catheter was returned in two segments.The marathon micro catheter appears to have been cut.The marathon proximal segment total length was measured to be ~12.5cm which is not within specification (specification: 165.0cm ± 2.5cm), the usable length was unable to be measured.The distal segment was measured to be 159.4cm and the distal floppy segment was measured to be ~25.1cm which is within specification (specification: 25.0cm +2.0cm -1.0cm).Onyx residue was found within the marathon hub.No damages were found with the marathon hub or distal tip.No onyx residue was found within the marathon micro catheter distal tip lumen.The entire surface of the marathon micro catheter was examined under magnification, no pin holes or ruptures were found.An in-house 0.010¿ mandrel was inserted into the marathon micro catheter distal tip lumen and became stuck at ~36.9cm from the distal tip.It is likely the proximal section of the marathon is occluded with the remaining onyx.No other anomalies were observed.Based on the dev ice analysis and reported information, the customer¿s reports of ¿catheter occlusion¿ was confirmed.There is no evidence suggesting that the marathon micro catheter was defective.However, it is likely that the onyx became exposed to water, saline or blood causing the onyx to solidify.This can occur in the hub, catheter lumen, or the needle used to draw the onyx from the vial.This regulatory report is being submitted as part of a retrospective review.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the onyx became stuck in the middle section of two different marathon microcatheters.Each product was removed, and the procedure was completed using a marathon microcatheter from another lot with no issues.It was noted the injections were not interrupted, and injection was at 90 second/0.25cc pace as per the ifu.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of dural arteriovenous fistulas (davf) and transarterial embolization (tae).It was noted the patient's vessel tortuosity was minimal.Ancillary devices include a emboy6f mpc, marathon, chikai10.The dead space was firmly filled with dmso.There was not any problem at all during flushing or injection.There was not any damage to the catheter.There was not any onyx reflux as it was stuck in catheter (solidify).

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17425617
• MDR Text Key: 320173281
• Report Number: 2029214-2023-01234
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: A919855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2019
• 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 Sex: Female