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

Model Number 145-5091-150

Device Problems Collapse (1099); Physical Resistance/Sticking (4012)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

The echelon-10 micro catheter was returned for analysis.The axium prime coil used in this event was not returned for analysis.Therefore, device analysis could not be performed.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per the axium prime coil ifu (instructions for use): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands¿ therefore, the echelon-10 micro catheter was found compatible for use with the axium prime coil.Upon visual examination, no issues were found with the echelon-10 hub.The echelon-10 catheter body was found to be kinked at ~35.7cm from the hub.The echelon-10 distal tip was noted pre-shaped.The echelon-10 distal tip/marker band was appeared to be punctured.No other anomalies were observed.The echelon-10 micro catheter total and usable lengths were measured to be within specifications.The echelon-10 micro catheter was flushed, water exited from the distal tip.An in-house coil was hydrated and was inserted through the echelon-10 hub, inner lumen and distal tip without issue; however, resistance was observed at damaged locations.Based on the returned devices, the echelon catheter was confirmed to have resistance during delivery as the echelon catheter was found to be damaged.It is likely that these damages occurred when the customer attempted to advance the axium prime coil through the echelon catheter against the reported resistance.It is possible that the patient tortuous anatomy during the procedure may have contributed to the reported resistance.There was no non-conformance to specification identified that led to the resistance during delivery.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.

Event Description

Medtronic received a report that the axium coil could not be delivered through the echelon microcatheter.After the devices were withdrawn, the coil was found to be stretched, and the distal tip of the catheter was crushed/broken.A continuous flush had been administered, and the coil was not repositioned. the devices were replaced, and the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for a ruptured, saccular aneurysm located in the left posterior communicating artery.The max diameter was 6.4mm, and the neck diameter was 4.2mm.The patient's blood flow was normal, and the vessel tortuosity was moderate.The access vessel was the left femoral artery, which was 7.78mm in diameter.Additional information received clarified that the catheter did not break and separate into pieces.The resistance was in the distal part of the catheter, and the coil came out of the introducer sheath smoothly.

• 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: 14881558
• MDR Text Key: 302602260
• Report Number: 2029214-2022-01092
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• 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: 06/30/2022

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: 05/17/2023
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B207137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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: 46 YR
• Patient Sex: Female