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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that under the guidance of the guidewire, the catheter successfully reached the lesion area.The catheter broke when the syringe pushed the contrast agent.The operation was carried out smoothly after replacing a catheter.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for onyx embolization for cerebrovascular malformation.Patient's vessel tortuosity was severe.Access vessel was the femoral artery with a 5mm diameter.
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 was received stating that the cause of the break was not determined.The marathon was broken before the injection of liquid embolic agent began, and it broke when the contrast agent was injected with a syringe during marathon angiography.There was¿continuous injection of the liquid embolic agent.The injection rate was followed as indicated in the competitor¿s ifu.The liquid embolic agent did not get embedded in an unintended location, it was injected.This event did not require¿medical intervention.The subject is recovering well from the procedure.It was confirmed that there were no issues with the onyx.
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
H3 product analysis: equipment used: vis (m-78210), 203cm ruler (m-83360) as found condition: the marathon catheter was returned for analysis within a shipping box and a plastic bio-pouch.Damage location details: the marathon catheter shaft was found to have detached from within the catheter hub.The strain relief and catheter hub were not returned.Upon inspection, there does not appear to be the presence of adhesive at the proximal end of the catheter shaft.No damage was found with the catheter shaft or distal tip.Testing/analysis: the marathon catheter shaft total length was measured to be ~168.5cm.Conclusion: based on the device analysis and reported information, the customer¿s report was confirmed as the marathon catheter shaft was found to have detached from within the catheter hub.An incomplete or compromised hub bond can lead to an unintended detachment of the catheter hub from the catheter body.However, the root cause could not be determined.A review of the device history records was performed.No potential manufacturing issues that may be related to this event were identified.The device met all manufacturing specifications upon release.No further manufacturing investigation or actions are recommended.H6 coding updated based on analysis findings.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: 22575895
• Report Number: 2029214-2025-01663
• Device Sequence Number: 9559795
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)270605(10)B741819
• 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): 10/02/2025

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: B741819
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 09/08/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/21/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG