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

Model Number	190-5091-150
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a different device¿s dispenser coil.The original packaging including its dispenser tray and tip protector was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 micro catheter hub.The distal tip and distal marker band were found separated from the remaining micro catheter.The distal segment was not returned for analysis.The edge of the break was found jagged.The inner liner was found stretched and damaged.No evidence of steam shaping was observed.Testing/analysis: the total length was measured to be ~152.8cm and the usable length was measured to be ~145.1cm, which is within specification (specification: total (ref) =152cm, usable = 144cm ± 1.5cm).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter break¿ was confirmed.The jagged edge occurring at the break area and the inner liner stretching indicates that the device surface failed due to tensile overload.However, the root cause could not be determined.Customer reported damage was found after preparation.It is possible the tip became damaged during removed from packaging if the tip protector is not pinched prior to removal of the tip.As the original packaging including the dispenser tray and tip protector were not returned for analysis, any contribution of the packaging towards the failure could not be assessed.There is an indication that the event could be related to a potential manufacturing issue, and therefore a dhr review will be performed.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 microcatheter tip was broken.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a small aneurysm of left ophthalmic artery.The vessel tortuosity was minimal.The access vessel was the femoral artery (5.2 mm diameter).After opening the package, it was found that the tip of the microcatheter was broken and could not be used normally.There were no p atient symptoms or complications associated with this event.Additional information received that there was no damage or evidence of tampering to device packaging.Additional information received that there was preparation completed prior to notice the catheter damage; it was found during hydration.

• 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: 19731361
• Report Number: 2029214-2024-01227
• Device Sequence Number: 12813749
• 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
• Report Date (Section B): 07/12/2024

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: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B575358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 07/12/2024
• 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: 51 YR
• Patient Sex: Female