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 10/23/2023

Event Type  malfunction  

Event Description

Medtronic received a report that during pushing the microcatheter echelon10 to go up under the guidance of the microguidewire, it was found that the tip end development mark was not developed.After it was withdrawn from the body, the loss of the tip end development mark was observed with the naked eye.The echelon and any accessories were prepared as indicated in the instructions for use (ifu).The echelon 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 surgery for an interventional embolization treatment of an aneurysm.The access vessel was the femoral artery with a diameter of 6.32mm.It was noted the patient's vessel tortuosity was minimal.

Manufacturer Narrative

Product analysis #(b)(4) : as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box; within an unsealed plastic biohazard pouch; within a sealed tyvek biohazard pouch and without a dispenser coil.The unknown guidewire and support catheter (if used) were not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 hub.The micro catheter body was found undamaged.The distal tip and marker band were found broken/separated from the remaining micro catheter and not returned for analysis.The edge of the break was found jagged and stretched.The distal segment was not returned for analysis.Testing/analysis: the total length was measured to be ~152.5cm and the usable length was measured to be ~144.8cm, which is within specification (specification: total (ref) = 152cm, usable = 144.0cm ± 1.5cm).The distal micro catheter length was measured to be 28.0mm, therefore, the missing distal segment is ~2.3mm to ~4.3mm long.Conclusion: the customer¿s report of difficulty navigation could not typically be confirmed through device analysis.Possible causes for difficulty navigation are incompatible devices, patient vessel tortuosity, damage to guidewire, damage to catheter, or lack of continuous flush.The catheter was found broken.The jagged edge and stretching occurring at the break area indicate that the device surface failed due to tensile overload.However, the root cause could not be determined.Customer reported devices were prepared per ifu, and vessel tortuosity as minimal.As no other information was reported and no ancillary devices were returned for analysis, the likely cause could not be determined.As the model and lot numbers of ancillary devices were not reported, compatibility could not be assessed.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: 18654572
• MDR Text Key: 334789786
• Report Number: 2029214-2024-00241
• Device Sequence Number: 1
• Product Code: KRA
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: B539008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female