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

Model Number	190-5091-150
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
Medtronic received information that a echelon catheter had resistance and a removal of the coating.It was difficult to push the echelon forward, when you feel outside of the patient the catheter surface you feel no longer the hydrophilic coating.With a new echelon there was no problems.The resistance was in the distal section of the catheter.The devices were prepare as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.The patient was undergoing aneurysm coiling.Vessel tortuosity was normal.The access vessel was the internal carotid artery (ica) with a diameter of 3mm.No patient symptoms or complications were reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3.Product analysis #(b)(4):equipment used: video inspection system (m-81805), ruler (m-83360), pin gauge sets (m-84082, m-84081), camera (panasonic lumix dmc-zs5), snap gauge (m-79527) as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an opened echelon-10 inner pouch.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, micro catheter body, or marker band.The distal tip was found slightly flattened.Under a microscope, the coating was examined.The coating was found damaged near the distal end.Testing/analysis: the echelon-10 total length was measured to be ~151.5cm and the useable length was measured to be ~143.3cm 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: based on the device analysis and reported information, 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 normal.As the guidewire used during the event was not returned for analysis, any contribution of the guidewire towards the difficulty navigation could not be assessed.The customer report of ¿coating removal during use¿ was confirmed.It is likely the coating became damaged due to the difficulty navigation.Other potential causes are advancing/retracting micro catheter against resistance or lack of continuous flush.The distal micro catheter was found flattened, also likely caused by the difficulty navigation.H6.Coding updated based on analysis results.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.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15882429
• Report Number: 2029214-2022-02013
• Device Sequence Number: 14720433
• Product Code: KRA
• UDI-Device Identifier: 00847536006294
• UDI-Public: 00847536006294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2023

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: 08/29/2024
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B439091
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/02/2022; 12/19/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/12/2022; 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: Female