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

Model Number	190-5091-150
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
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 a guidewire punctured the distal section of the echelon catheter.The patient was undergoing surgery for treatment of an intracranial aneurysm.It was noted the patient's vessel tortuosity was normal.The access vessel was the right femoral artery with a diameter of 7mm.It was reported that when the guide wire and the microcatheter were pushed to go upper coaxially, it was found that the guide wire passed through the wall of the microcatheter.There was no friction or difficulty during insertion of the guidewire/stylet.Aside from the puncture, there was no other damage to the catheter.There was no kink or damage on the guidewire/pushwire/stylet.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.
Event or Problem Description
Additional information was received reporting that the cause of the puncture with the guidewire was the wall of microcatheter was damaged.
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.Product analysis: equipment used: video inspection system (m-81805), ruler (m-83361), pin gauge sets (m-84083, m-84081), camera (panasonic lumix dmc-zs5), in-house guidewire as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The unknown guidewire used during the event visual inspection/damage location details: no damages were found with the echelon-10 hub.No damages or irregularities were found with the echelon-10 micro catheter body.The distal tip and marker band were found crushed (figures d, e, & f).The catheter tip appears to have been shaped.The tip was found kinked proximal to the distal marker band with a large break found kinked location (figures d & e).The break edge appears stretched and jagged.Dried blood was found within the break (figure e).Testing/analysis: the echelon-10 micro catheter total length (to the proximal marker band) was measured to be ~152.3cm and the usable length (to the proximal marker band) was measured to be ~144.5cm, which is within specification (specification: total (ref) = 152cm, usable: 144cm ± 1.5cm).The micro catheter was flushed, and water exited the rupture.An in-house guidewire was inserted into the echelon-10 micro catheter hub, through the catheter and exited the break, pushing out the blood.No resistance was encountered.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture with guidewire¿ was confirmed.Possible causes of the break are using a heat source other than steam, holding the catheter tip too close to the heat source (1 inch), not using the shaping mandrel, due to holding the device against the heat source too long (approximately 10 seconds), or removing the shaping mandrel prior to the catheter cooling following tip shaping.The catheter wall was found thinning, potentially due to the steam shaping, or due to the kinking.The break/puncture would have occurred at the thinning location.H6.Coding updated based on analysis findings.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: 21216732
• Report Number: 2029214-2025-00191
• Device Sequence Number: 19712338
• Product Code: KRA
• UDI-Device Identifier: 00847536006294
• UDI-Public: 00847536006294
• 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): 04/14/2025

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: 04/11/2025
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B547843
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 03/22/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/19/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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: 65 YR
• Patient Sex: Male