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

Model Number	105-5056
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that while pushing the marathon to go upper, the operator found that the resistance was too great and could not push it into place.After repeated attempts, the operator withdrew the floating microcatheter and filed a product complaint.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient is alive with no injury.The patient was undergoing surgery for treatment of an arteriovenous malformation.The access vessel was the femoral artery with a diameter of 2mm.Additional information was received.Lesion characteristics were unknown.After the external support pathway was established, the gu idewire guided the marathon.Repeated attempts failed to advance it further, but after replacing it with another marathon, the device could be advanced smoothly.The cause of the resistance and difficult navigation was not determined.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the marathon catheter was returned within a shipping box and a plastic bio-pouch.¿ visual inspection/damage location details: no damage was found with the marathon catheter hub.Marathon catheter distal tip bent with the catheter body broken at the proximal edge of the distal marker.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter resistance¿ and ¿difficulty navigation¿ reports could not be confirmed.Possible causes of ¿catheter resistance¿ include incompatible devices, patient vessel tortuosity, catheter damage, guidewire damage, insufficient catheter flushing, or insufficient guidewire hydration.Possible causes of ¿difficulty navigation¿ include incompatible devices, patient vessel tortuosity, guidewire damage, catheter damage, or lack of continuous flush during delivery.The device and accessories were prepared as indicated in the ifu and the catheter was flushed as indicated in the ifu, ruling out insufficient catheter flushing and insufficient guidewire hydration.The guidewire used in the event was not returned and the make/model was not provided.Therefore, any contributing factors from the guidewire could not be assessed.Information regarding patient vessel tortuosity was not provided.Damage to the marathon catheter distal tip (bent/broken) was likely caused by the advancement against resistance.The cause of the reported event could not be determined.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.

• 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: 23427551
• Report Number: 2029214-2025-02301
• Device Sequence Number: 9853819
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)280217(10)D021909
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/30/2025

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: D021909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 50 KG