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

Model Number	145-5091-150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicated a reportable event.H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed biohazard pouch and within a sealed tyvek pouch.Visual inspection/damage location details: the echelon-10 total length was measured to be ~155.3cm.The echelon-10 useable length was measured to be ~148.0cm which is within specification.Upon visual examination, no issues were found with the echelon-10 hub or catheter body.The distal tip was found to be damaged (break).The distal tip was noted to be pre-shaped.No other anomalies were observed.Conclusion: based on the customer¿s report of ¿catheter kink/damage¿ was confirmed as the catheter body was found to be broken.However, the root cause for the 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 an echelon catheter tip was damaged.The patient was undergoing surgery for treatment of an aneurysm of the left internal carotid artery clinoid segment.It was noted the patient's vessel tortuosity was moderate.The access vessel was the right femoral artery with a diameter of 6.2mm.It was reported that due to the tortuous vascular path of the patient, the 6f-envoy da+125cm multifunctional tube was placed at the level of the cavernous sinus segment of the left internal carotid artery with the assistance of a 0.035in guidewire.The best working angle was selected, and under the roadmap, a micro-guidewire (synchro soft) was used to assist the micro-catheter (headway-21) to be placed at the distal end of the m1 segment of the left middle cerebral artery in preparation for stent deployment, and the micro-guidewire was withdrawn.The same micro-guidewire was used to assist the micro-catheter (echelon 145-5091-150) to be placed into the aneurysm.The tip of the micro-catheter was found to be damaged, so a new micro-catheter 105-5091-150 was opened and placed into the aneurysm.The micro-guidewire was then removed.The target 2.5/4 coil was filled into the aneurysm.Due to the wide neck of the aneurysm, the coil partially protruded into the parent artery.The rebridge 4.5/24mm (specification: m214524, lot number: 21870003, included in the clinical trial) stent was selected for semi-deployment via microcatheter and then filled with target 1.5/3 coil coil.After the stent was fully deployed, angiography showed that the stent completely covered the aneurysm, with the distal end of the stent located in the communicating segment of the left internal carotid artery and the proximal end located in the cavernous sinus segment of the left internal carotid artery.Covered branch vessels: ophthalmic artery, branch vessels were unobstructed, guided catheter angiography showed that the aneurysm was mostly embolized (raymond iii grade), the coil was well positioned, the aneurysm-bearing artery was unobstructed, and no obvious abnormalities were found in the distal vessels.The operation was then ended.Angiography catheters used during the operation: cordis apt , no other auxiliary treatment devices were used during the operation; no device defects or adverse events occurred during the operation.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.Additional information received reported that the cause of the catheter damage was unknown.Ancillary devices include a 6f terumo puncture sheath, 6f envoy da guide catheter, stryker synchro 0.014 in 2 meter guidewire.

• 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: 21163137
• Report Number: 2029214-2025-00146
• Device Sequence Number: 9340133
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• 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
• Report Date (Section B): 01/15/2025

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 Expiration Date: 06/05/2025
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B575130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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: 48 YR
• Patient Sex: Female