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

Model Number 145-5092-150

Device Problem Collapse (1099)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis (b)(4):equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgs145-5091-150 rev.Ar as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box and within an opened echelon-10 inner pouch.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 micro catheter hub.No damages were found with the echelon-10 micro catheter body.The distal tip and marker band were found separated and not returned for analysis.The edge of the break was found jagged and slightly stretched.Some evidence of tip shaping was found (slightly rough surface and wrinkles in the coating).Testing/analysis: the total length was measured to be ~152.6cm and the usable length was measured to be ~144.7cm, which is within specification (specification: total (ref) = 152cm, usable = 144.0cm ± 1.5cm).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter crushed¿ was not confirmed.However, the catheter was found broken.The jagged edge and slight stretching occurring at the break area indicate that the device surface failed due to tensile overload.However, the root cause could not be determined.It is possible the tip became damaged during customer shaping process or when the device was removed from packaging.Customer reported the damage was found after the device was hydrated.Customer did not report any steam shaping.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 catheter tip was damaged.It was reported that the catheter was crushed at the distal end.The reported device and any accessory devices were prepared and 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 surgery for treatment of an intracranial aneurysm.It was noted the patient's vessel tortuosity was minimal.The access vessel was the right femoral artery with a diameter of 7.6mm.Additional information received that the damage was not noticed upon opening the package.Hydration was the prep performed prior to the damage being seen.There was no damage or evidence of tampering to device packaging.

• 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: 17641225
• MDR Text Key: 322159608
• Report Number: 2029214-2023-01511
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006270
• UDI-Public: 00847536006270
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: 145-5092-150
• Device Catalogue Number: 145-5092-150
• Device Lot Number: B335886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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