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

Model Number	105-5092-150
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition: the echelon-14 micro catheter was returned for analysis within a shipping box, within shrink wrap, within an opened echelon-14 outer carton and within an echelon-14 inner pouch.Visual inspection/damage location details: the echelon-14 micro catheter was found cut at ~147.8cm from the distal end with the inner braid also cut.The proximal segment, including the hub, was not returned for analysis.The distal ~1.5cm of the echelon-14 micro catheter was found shaped.The distal tip and distal marker band were found ovalized.Testing/analysis: the echelon-14 micro catheter could not be used for resistance testing due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance during device delivery¿ could not be confirmed but cannot be ruled out.Resistance testing could not be performed as the micro catheter was cut, and the hub/proximal micro catheter were not returned.The cause of the cut cannot be determined.It is possible the ovalized catheter tip contributed towards the resistance.Possible causes for catheter damage include, but not limited to, patient vessel tortuosity, insufficient continuous flush, guidewire/coil damage, or insufficient device hydration.The cause of the catheter damage could not be determined.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 introduction into two echelon 14 microcatheters, an axium coil encountered resistance and could not be pushed into the catheter.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of a cerebral aneurysm.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).Ancillary devices included: axium coil.

• Brand Name: ECHELON
• 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: 24246105
• Report Number: 2029214-2026-00209
• Device Sequence Number: 9618351
• Product Code: KRA
• UDI-Device Identifier: 00847536005983
• UDI-Public: (01)00847536005983(17)261021(10)B806491
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 105-5092-150
• Device Catalogue Number: 105-5092-150
• Device Lot Number: B806491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: 63 YR
• Patient Sex: Male