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

Model Number	105-5056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 patient was undergoing treatment for arteriovenous malformation.It was noted that the patient's vessel tortuosity was normal.The access vessel was the femoral artery, with 6.6mm diameter.It was reported that during the surgery, while shaping the tip of the marathon catheter with a shaping needle, it was found that the mark tip had detached.A new marathon catheter was then used to continue the procedure.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).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.
Event or Problem Description
Additional information was received stating that the cause of the marker tip detachment was not determined.No resistance, abnormality, or difficulty was noticed while shaping the catheter tip, and no force or unusual technique was required during shaping.The detached marker tip remains stuck on the molding needle.The original packaging was intact and undamaged upon opening.
Additional Manufacturer Narrative
Product analysis as found condition: the marathon catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.No shaping needle was returned.Damage location details: no damages were found with the marathon catheter hub.No bends or kinks were found with the marathon catheter body.The marathon catheter distal marker/tip was found to be separated from the catheter and not returned.The tubing material of the separated end was found to be damaged (jagged edges), indicating the tip separated.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿marker band dislodged¿ was able to be confirmed, as the marathon catheter distal marker/tip was found to be separated from the catheter.In addition, the broken segment (marker band) was not returned; therefore, any contribution the marker band had towards the damage could not be assessed.The likely cause for the marker band dislodge was determined to be caused by ¿catheter tip shaping¿.The report mentions that ¿while shaping the tip of the marathon catheter with a shaping needle, it was found that the mark tip had detached¿.Via the ifu ¿shape the catheter by holding the shaped portion approximately 1 inch (2.5 cm not less than 1 cm) from the steam source for about 20 seconds (do not exceed 30 seconds); in addition, allow catheter tip to cool in air or saline prior to removing mandrel.No damaged was mentioned prior to tip shaping.The report notes that the marker band was stuck on the shaping needle; however, the shaping needle was not returned for further assessment.This was unable to be verified.The reported device and any accessory devices were prepared and 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: 23803950
• Report Number: 2029214-2025-02628
• Device Sequence Number: 9270704
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: (01)00847536005914(17)280203(10)D017482
• 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): 02/20/2026

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: D017482
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/29/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/14/2026; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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