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

Model Number	105-5056
Medical Device Problem Codes	Leak/Splash (1354); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for embolization.It was noted that the patient's vessel tortuosity and the access vessel were unknown. it was reported that the marathon catheter was opened and, when prepared, showed leakage; therefore, the item was not used.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No medical or surgical intervention was needed to prevent permanent impairment of a function, and the event did not lead to or extend patient hospitalization.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 was received.Vessel tortuosity was unknown.The cause of the leak was undetermined.There was no damage or evidence of tampering to device packaging.The device has never been used.It was removed from its original packaging, and during the pre-use washing/preparation process, it was discovered to be punctured.No other catheter was used as a replacement.The doctor continued the procedure with another device.
Additional Manufacturer Narrative
H3: no damages were found with the marathon hub.The micro catheter was found ruptured at 24.6cm from the distal end.The distal tip and distal marker band were found flattened.The guidewire pusher was found extending out the hub 30.6cm.The guidewire pusher was found kinked at ~6.9cm from the proximal end.No damages were found to the guidewire.The marathon total length was measured to be 174.5cm, the usable length was measured to be 163.4cm, which is within specification (specification: total (ref): 170.0cm, usable: 165.0cm ± 2.5cm).The returned guidewire could not be advanced out of the marathon micro catheter and was retracted out against resistance.The marathon was flushed, and water exited the ruptured location.The guidewire outer diameter was measured to be 0.0127¿.Based on the device analysis and reported information, the customer¿s report of ¿catheter leak¿ was confirmed.The leak was found to be due to the rupture found.It is likely the flattened distal tip caused over pressurization, leading to the rupture and reported leaking.It is possible catheter flattening occurred during removal from packaging or during preparation.The likely cause could not be determined.The guidewire outer diameter was measured to be 0.0127¿, which is not compatible for use with the marathon micro catheter, which is rated to be used with a 0.010¿ guidewire.It is possible the oversized guidewire or the flattened marker band caused the resistance found during analysis.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: 22639362
• Report Number: 2029214-2025-01712
• Device Sequence Number: 9695177
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)270725(10)B764575
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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: B764575
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 11/13/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/27/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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 Sex: Female