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

Model Number	105-5091-150
Medical Device Problem Codes	Material Deformation (2976); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
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 had an aneurysm at the left ophthalmic artery segment and was scheduled for coil embolization.After femoral artery puncture and establishment of the access route, the microcatheter was advanced, but the distal marker point was not visible under fluoroscopy.Upon withdrawal of the microcatheter, it was found that the microcatheter wall at the distal marker point was damaged.To ensure surgical safety, a new microcatheter was used, and the procedure was completed successfully.Damage was at the distal section.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 aneurysm embolization.Access vessel was the femoral artery.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): the echelon-10 micro catheter was returned for analysis within a shipping box and within a sealed biohazard pouch.Visual inspection/damage location details: upon visual examination, no issues were found with the echelon-10 hub.The catheter body was found to be damaged at ~3.1cm from distal tip.The damage appeared to be consistent with tip shaping.The distal tip was found to have been shaped.No other anomalies were observed.Testing/analysis (including sem reports): the echelon-10 total length was measured to be ~155.5cm.The echelon-10 useable length was measured to be ~147.4cm which is within specification.Conclusion: based on the reported information and the device analysis the customer¿s report of ¿catheter kink/damaged¿ was confirmed as the distal tip was found to be damaged.The damage appears to be consistent with tip shaping damage.The likely cause for reported failure was user error.Per ifu, ¿shape the catheter by holding the shaped portion approximately 1in (2.5cm not less than 1cm) from steam source for about 20 seconds (do not exceed 30 seconds)¿.However, the root cause 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
Additional information was received that after the microcatheter was advanced, the distal marker point was not visible under fluoroscopy.Upon removal of the microcatheter, it was found that the microcatheter wall at the distal marker point was damaged.
Additional Manufacturer Narrative
B5: additional information added to event summary.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: 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: 24291664
• Report Number: 2029214-2026-00246
• Device Sequence Number: 9415199
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: (01)00847536005969(17)270707(10)D050263
• 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): 03/26/2026

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: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: D050263
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 03/23/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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 Age: 63 YR
• Patient Sex: Male