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

Model Number	105-5056
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Ischemia (1942); Muscle Weakness/Atrophy (1967); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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 the marathon catheter distal end broke.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm.The access vessel was the femoral artery.It was noted the patient's vessel tortuosity was normal.It was reported that during arteriovenous malformation embolization with onyx, a fracture occurred approximately 25 cm from the distal end of the microcatheter, leaving the distal segment inside the patient¿s body when the catheter was withdrawn at the end of the embolization.The reported device and any accessory devices were prepared as indicated inthe instructions for use (ifu).The catheter was flushed per the ifu.No patient symptoms or complications were associated with this event.Ancillary devices include onyx.
Event or Problem Description
Additional information received reported that the cause of the event was not determined.The patient experienced ischemic symptoms and weakness in the corresponding upper limb.It was unknown if there was any medical or surgical interventions required.It was confirmed that one vial of onyx was actually injected, not two.A continuous infusion was used, approximately two minutes from injection to extubation.There was reflux of approximately 1 cm.The dead space of the delivery catheter was filled with dmso.The marathon catheter was not removed from the patient.
Additional Manufacturer Narrative
H3: device received, analysis is in progress.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
Product analysis as found condition: the marathon micro catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Visual inspection/damage location details: no damages or irregularities were found with the marathon hub.Onyx residue was found within the marathon hub.No damages were found with the marathon hub (figure c).The marathon micro catheter body was found broken at ~140.6cm from the proximal end.Therefore, ~21.9cm to ~26.9cm of the distal micro catheter was missing.The break edge exhibit stretching and jagged edges (figure d).Testing/analysis: the marathon total length and usable length could not be reliably measured as the distal segment was not returned for analysis.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.It is possible that the onyx solidified, entrapping the distal tip within the aneurism, causing the micro catheter to break when retracted.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: 23099839
• Report Number: 2029214-2025-02051
• Device Sequence Number: 8685805
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)271213(10)D006846
• 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): 11/30/2025

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: D006846
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 11/19/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/24/2025; 11/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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
• Patient Age: 39 YR
• Patient Sex: Male