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

Model Number	105-5091-150
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the guidewire perforated the echelon catheter before entering the patient.The patient was undergoing an aneurysm embolization.The accessed vessel was the femoral artery with a diameter of 7.1 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that after the intermediate catheter was positioned during the procedure and the echelon 10 was shaped, the operator prepared to advance the microcatheter into the aneurysm with the guidance of a micro guidewire.After opening the package of the mi crocatheter, the micro guidewire was introduced into the microcatheter.During manipulation, the tip of the micro guidewire perforated the tip of the microcatheter, rendering the microcatheter unusable.The microcatheter had not yet entered the patient.After care ful consideration, the operator decided to replace the microcatheter with a new one.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a 6f 115 barty medical sheath, prime 3-6 coils.
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
H3: device received, analysis is in progress.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 patient was undergoing treatment for an internal carotid artery aneurysm.The surgeon suspected a problem with the material at the tip of the microcatheter caused the event.The guidewire used was not a medtronic device.
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): an echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed biohazard pouch and within an opened echelon-10 micro catheter inner pouch.Visual inspection/damage location details: upon visual examination, no issues were found with the echelon-10 hub or catheter body.The distal tip was noted to be pre-shaped.The distal tip was found to be damaged.Upon further inspection there appeared to be a puncture at proximal end of the distal marker band.No other anomalies were observed.Testing/analysis (including sem reports): the echelon-10 total length was measured to be ~155.3cm.The echelon-10 useable length was measured to be ~147.7cm which is within specification.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture¿, was confirmed as the echelon-10 distal tip was found to be punctured.User error is the likely cause of the customers report for ¿catheter puncture¿.The customer reported after manipulation of guidewire, the guidewire perforated the distal tip of echelon micro catheter.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: 23631823
• Report Number: 2029214-2025-02480
• Device Sequence Number: 18525810
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: (01)00847536005969(17)270317(10)D026123
• 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): 01/26/2026

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: D026123
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 01/08/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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