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

Model Number 145-5091-150

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis #(b)(4): equipment used: video inspection system ((b)(6)), ruler ((b)(6)), camera (panasonic lumix dmc-zs5), snap gauge ((b)(6)) drawing(s) referenced: dwgs145-5091-150 rev.At as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box; within an unsealed plastic biohazard pouch and within a sealed tyvek biohazard pouch.No other ancillary devices were returned for analysis.Visual inspection/damage location details: no flash or hub mold were found within the hub.No damages or irregularities were found with the echelon-10 hub.The echelon-10 catheter body was found damaged (scraped/cut) between ~99.0cm and ~102.2cm from the proximal end.The catheter was also found damaged (scraped/cut) and partially melted at ~129.0cm and ~131.0cm from the proximal end.The distal tip and marker band were found damaged (partially crushed, and surface slightly melted).Testing/analysis: the echelon-10 total length was measured to be ~152.8cm and the useable length was measured to be ~145.1cm which is within specification (specification: total (ref) = 152cm; usable = 144cm ± 1.5cm).The outer diameter at the distal end of the micro catheter was measured to be 0.025¿, which is within specification, (specification: 0.026¿ max).Conclusion: the customer report of ¿difficulty navigation¿ could not typically be confirmed through device analysis.Possible causes are patient vessel tortuosity, damage to guidewire, damage to catheter, or lack of continuous flush.Customer reported all devices were prepared per ifu, and vessel tortuosity as minimal.As no other ancillary devices used during the event were returned for analysis, any contribution of the other devices towards the difficulty navigation could not be assessed.The surface of the catheter was found with severe scraping/cuts.Customer did not report any such damages during preparation/inspection per ifu.Therefore, it is possible the damages occurred during use.However, the severity of the damages found is not typical of use or any known failures.The cause of the damages could not be determined.The distal catheter was found partially melted.It is possible the partial melting occurred due to improper steam shaping (using a heat source other than steam, holding the catheter too close to the heat source ,or due to holding the device against the heat source too long).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that during navigation of the echelon microcatheter with the guidewire, the middle of the catheter could not go to the upper right position, and the problem could not be solved after repeated adjustments.The catheter and any accessories 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.The patient was undergoing an interventional embolization procedure for the treatment of an aneurysm.The access vessel was the femoral artery with a diameter of 4.33mm.It was noted the patient's vessel tortuosity was minimal.

• Brand Name: ECHELON
• Type of Device: 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18506371
• MDR Text Key: 333322856
• Report Number: 2029214-2024-00105
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B510842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1