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

Model Number	105-5056
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that there was a marathon leak and damage.The patient was undergoing surgery for treatment of intra-arterial chemo.The access vessel was the ophthalmic artery with a diameter of 3mm.It was noted the patient's vessel tortuosity was moderate.The patient is alive with no injury.It was reported that during the procedure, marathon batch d063934db2 was a problem.At the time of injecting the contrast and performing the passage of the microguide, it was evident that the contrast was coming out of the side of the device, observing that the microcatheter was damaged broken.Faced with this situation, the doctor proceeded to return the microcatheter and requested a new one.The second microcatheter delivered was used without problems and worked correctly during the procedure.There was a catheter leak in the proximal section.The catheter was inspected/tested prior to use.The leak was observed during use of the catheter.The catheter was crushed.It was indicated that there were patient symptoms or complications associated with this event.There was medical or surgical intervention needed to prevent a permanent impairment of function.The event led to or extended patient hospitalization.There was no injury as a result of the event.The device and any accessories were prepared as indicated in the ifu.Additional information was received reporting the patient is having a good recovery.There are no procedural/post-procedural imaging (ct, angio, etc.) available.The patient did not experience any symptoms related to this event.The patient suffered no injuries.The catheter damage/lead did not lead to or extend patient hospitalization.There was no medical/surgical intervention needed as a result of the catheter damage/leak.

• Brand Name: MARATHON
• Common Device Name: 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24405661
• Report Number: 2029214-2026-00297
• Device Sequence Number: 13198645
• Product Code: KRA
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: D063934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown