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

Model Number	105-5056
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 during tumor-feeding vessel embolization, a 105-5056 microcatheter was navigated to the target vess el under the guidance of micro-guide wire.During the procedure, the guidewire became stuck within the microcatheter and could not be withdrawn.The operator replaced it with another microcatheter to continue the procedure and returned the affected microcatheter.The reported device and any accessory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 tumor-associated vascular embolism.It was noted the patient's vessel tortuosity was normal.Access vessel was the right femoral artery with an 8mm diameter.Ancillary devices include a traxcess guidewire.
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 stuck was not determined.
Additional Manufacturer Narrative
H3: product analysis as found condition: the marathon catheter and the non-medtronic guidewire were both returned within a shipping box and within an opened marathon inner pouch.Damage location details: the device was returned with the non-medtronic guidewire stuck in the catheter starting from the hub and exiting the distal tip.No damage could accurately be confirmed with the marathon catheter due to its returned condition.Some stretching was noticed near the distal segment.No other anomalies were observed.Testing/analysis: during testing, the marathon catheter was able to be flushed with water, that was able to exit the distal tip, with some resistance.Next, an attempted to retracted the guidewire from the marathon failed due to great resistance encountered.Some accordioning was noticed during the attempt to retract the guidewire.The non-medtronic (traxcess) guidewire was measured and found to be 0.11¿, which was found to be out of specification.Conclusion: based on the device analysis and reported information, the customer¿s ¿catheter resistance¿ report was confirmed, as the guidewire was returned stuck within the marathon catheter.A possible cause for the resistance could have occurred from using an ¿incompatible device/s¿.During testing, the guidewire (traxcess) was measured via an in-house snap gauge (m-79527), which marks the guidewire distal segment at 0.011¿.As the guidewire¿s (traxcess) pusher od (outer diameter) was found out of specification, resistance can occur if the guidewire is advanced too far out from within the marathon catheter.As indicated in the instructions for use (ifu), ¿the marathon¿ is not compatible with non-hydrophilically coated guidewires greater than 0.010¿ in diameter.¿ however, the cause of the resistance could not be determined.A few other possible causes of ¿catheter resistance¿ include catheter damage, guidewire damage, insufficient catheter flushing, and/or flush rate too low.No mention of a continuous flush was reported.It was noted that the patient's vessel tortuosity was normal.The reported device and any accessory devices were prepared, and the catheter was flushed as indicated in the instructions for use (ifu).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: 23544017
• Report Number: 2029214-2025-02394
• Device Sequence Number: 18524362
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)280116(10)D012979
• 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): 01/28/2026

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: D012979
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 01/15/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: Female