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

Model Number	190-5091-150
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a coil encountered resistance at the hub of a echelon catheter.The patient was undergoing surgery for treatment of a coil embolization with an anterior cerebral artery (aca) access vessel of 2.5mm.It was noted the patient's vessel tortuosity was moderate.It was reported that the coil got caught at the hub during insertion which occurred twice.The hydro soft, and target tetra size was unknown, so it was determined to be a problem with the catheter.There was resistance at the hub of the catheter.The sheath tip was firmly positioned at the hub.The catheter was collected, changed to sl10 then the procedure continued.Devices were prepared as indicated in the package insert.No patient complications were associated with this event.Additional information received reported that the cause of the resistance was not determined.The concomitant coil was not a medtronic product.
Additional Manufacturer Narrative
H3" product analysis: equipment used: video inspection system (m-81805), 203cm ruler (m-83360), in-house coil (model: qc-4-8-3d, lot: 9673450), in-house mandrel ¿as found condition: the echelon-10 catheter was returned for analysis inside a clear sealed biohazard plastic pouch and a shipping box.¿damaged location details: the echelon-10 catheter tip and marker were examined, and no damage was noted.The catheter body was observed to be broken at ~8.3cm and kinked at ~13.5cm from the proximal end of the catheter hub.No voids or flashes were found in the catheter hub.No other anomalies were found.Testing/analysis: the echelon-10 catheter total length was measured to be ~154.5 cm.The usable length was measured to be ~147.0cm, which is within the specification (specification: total = 155cm (ref), usable = 147.0 ± 1.5cm).The catheter hub was flushed with water, and water exited through the broken end.The catheter hub was tested using an in-house coil, and it became stuck soon after entering.A mandrel was inserted, and resistance was felt at the fuse joint between grilamid and the proximal catheter.The inner diameter of the hub was measured at 0.0165 inches, which is within specification (minimum 0.0165 inches).No gap was found between the hub and the microcatheter grilamid.Conclusion: based on the reported information and device analysis, the customer¿s ¿catheter resistance at hub¿ report was confirmed.Also, the catheter was found to be damaged (broken/kinked).However, the cause of the damage could not be determined.During in-house functionality testing, it was determined that the resistance was caused by a ¿step¿ between the grilamid and the proximal catheter.Also, the catheter was found to be damaged (broken/kinked).However, the cause of the damage could not be determined.The step in the hub occurs when grilamid (nylon tubing) is not fully fused to the catheter during catheter assembly.It is possible that the ¿hub step¿ forming was due to manufacturing failure.There was an indication that the event was related to a potential manufacturing issue.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: 25186471
• Report Number: 2029214-2026-00894
• Device Sequence Number: 10652789
• Product Code: KRA
• UDI-Device Identifier: 00836462002357
• UDI-Public: (01)00836462002357(17)270515(10)D039240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/15/2026

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: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: D039240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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: Unknown