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

Model Number	190-5091-150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis # (b)(4) : equipment used: vis ((b)(6)), 203cm ruler ((b)(6)) document used: (b)(4) as found condition (condition of returned device): an echelon-10 micro catheter was returned for analysis within a shipping box and within sealed biohazard pouch.Visual inspection/damage location details: the echelon-10 total length was measured to be ~155.4cm.The echelon-10 useable length was measured to be ~147.6cm which is within specification.No damages were found with the echelon hub; however, what appeared to be saline residue was found within hub.No bends or kinks were found with the echelon-10 body.No other anomalies were observed.Testing/analysis (including sem reports): the echelon-10 micro catheter was flushed; water was found to be leaking from within the inner strain relief and the distal tip.The outer and inner strain reliefs were removed, the catheter was re-flushed, and water was found to be leaking from a hole in the catheter shaft at ~2.0cm from the hub.The damaged surface shows evidence of skive damage in the proximal direction which created a hole through the catheter shaft and inner liner subsequently causing the catheter to leak.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter leak at hub/strain relief¿ was confirmed.This event most likely originated from the echelon hub assembly process step.However, the root cause could not be determined.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 a report that the echelon catheter was found to have a leak at the hub.The patient was undergoing surgery for treatment of an aneurysm.The accessed vessel was the femoral artery with a diameter of 3 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that during the preoperative preparation, the microcatheter was opened.When flushing, water leakage was found at the connection between the hub at the proximal end of the catheter and the microcatheter, making it unusable.This problem was eliminated when replacing with another microcatheter, and the surgery was successfully completed.The reported device and any accessory devices 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.Additional information received that large aneurysm in the c4.The catheter leak was not man-made but the cause is unknown.

• 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: 18812515
• Report Number: 2029214-2024-00356
• Device Sequence Number: 14580905
• 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): 02/29/2024

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: 03/06/2025
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B528798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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: 50 YR
• Patient Sex: Male