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

Model Number	105-5056
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during embolization a leakage was found in the proximal part of the marathon catheter.The leak was observed during use.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient is alive with no injury.The patient was undergoing surgery for embolization treatment.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoralis with a vessel diameter of 1.5cm.Ancillary devices include a medox 18 liquid embolic.
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 that the cause of the leak was not determined.
Additional Manufacturer Narrative
Product analysis: as found condition: the marathon catheter was returned for analysis within a shipping box, a plastic bio-pouch, and an open marathon inner pouch (d027264).Visual inspection/damage location details: liquid embolic residue was found with the marathon catheter hub.No damage was found with the catheter hub.No bends or kinks were found with the marathon catheter body.However, the catheter body was found ruptured 5.3cm from the catheter distal tip.The characteristic of the catheter rupture is consistent with over-pressurization.The marathon catheter distal tip was found to be in good condition.No liquid embolic was found within the distal tip lumen.Testing/analysis: none 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: 22292269
• Report Number: 2029214-2025-01423
• Device Sequence Number: 8467472
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)280317(10)D027264
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/28/2025

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: D027264
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 08/05/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 06/27/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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 Sex: Unknown