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

Model Number	105-5056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for arteriovenous malformation embolization.It was noted that the patient's vessel tortuosity was normal.The access vessel was the right femoral artery, with 14.2mm diameter.It was reported that the marathon catheter tip was broken off inside the body.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
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.
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
Additional information received reported the tip breakage was a device issue.The patient is recovering well.No symptoms or complications were reported.There were no issues that resulted in the damage that was found.The distal tip of the catheter broke.The portion was removed by operation from the patient.There was no resistance or unusual behavior noted during device manipulation prior to the break.The break was identified during advancement or withdrawal.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the marathon catheter was returned within a shipping box and a sealed bio-pouch.The marathon catheter was returned separated into two segments.¿ visual inspection/damage location details: liquid embolic residue was found within the marathon catheter hub.The marathon catheter body was found separated at ~147.3cm from the proximal end of the catheter hub.The catheter separated end exhibited plastic deformation (jagged edges/stretching) indicating the catheter likely separated due to tensile failure.Marathon catheter distal separated segment was found stretched.¿ testing/analysis: the total length of the distal segment was measured to be ~11.5cm.When compared to the product drawing, ~12.5cm of the marathon catheter was not returned.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter separation/break¿ report was confirmed as the marathon catheter body was found separated.Possible causes of ¿catheter separation/break¿ include user operational context if user advances or retrieves intraluminal device against resistance, vasospasm, patient vessel tortuosity, entrapment in vessel, more than 20cm of traction was applied, fast catheter retrieval technique, or user applies excessive force, thus exceeding tensile strength of tubing material.However, 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: 22559419
• Report Number: 2029214-2025-01652
• Device Sequence Number: 18566972
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)270523(10)B736499
• 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,Followup,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: B736499
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 09/02/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 07/28/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male