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

Model Number 145-5091-150

Device Problem Leak/Splash (1354)

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

Event Date 09/02/2022

Event Type  malfunction  

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 Description

Medtronic received a report that the proximal part of the echelon 10 microcatheter leaked during preparation. the catheter was replaced, and the patient did not experience any injury, symptoms, extended hospitalization, or additional medical/surgical intervention.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for cerebral embolization.The patient's vessel tortuosity was normal.The access vessel was the femoral artery, which was 4mm in diameter.

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 Description

Additional information received reported that there was no kink in the catheter, and the cause of the event was not determined.

Manufacturer Narrative

H3: the echelon-10 micro catheter was returned for analysis.No damages or irregularities were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.No damages were found with the echelon-10 distal marker/tip.The echelon-10 total length was measured to be ~152.4cm and the useable length was measured to be ~144.7cm which is within specification (specification: total (ref) = 152cm; usable = 144.0 cm ± 1.5cm).The echelon-10 micro catheter was flushed, and water was observed exiting from under the outer strain relief.The outer strain relief was removed, and a gap was found between the hub and the catheter shaft.The leak was found to be exiting between the catheter and the hub at this location.Based on the device analysis and reported information, the customer¿s report of ¿catheter leak¿ was confirmed.It is likely the gap step in the hub is formed when grilamid (nylon tubing) is not fully fused on to the catheter during hub assembly.The potential for forming a ¿hub step¿ is most likely attributed to manufacturing failure.Review of device history record found the lot has passed 100% hub bonding visual inspection and 100% leak test @50psi ± 2psi.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
• 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: 15386036
• MDR Text Key: 302789720
• Report Number: 2029214-2022-01521
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup,Followup
• Report Date: 11/16/2022

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 Expiration Date: 01/11/2024
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B320767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 11/10/2022
• Supplement Dates FDA Received: 10/27/2022; 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sex: Female