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

Model Number 105-5091-150

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: as found condition: the echelon-10 micro catheter was returned for analysis inside of a biohazard bag and a shipping box.Visual inspection/damage location details: upon visual inspection, no issues or irregularities were found with the echelon-10 micro catheter hub.The catheter body appeared to be kinked at 41.0cm and 64.0cm from the catheter hub.The echelon-10 micro catheter distal tip appeared to be shaped.The echelon-10 micro catheter distal tip and marker band were found to be separated and missing.The outer and inner tubing material at the broken end exhibited with jagged edges and stretching.The inner elliptical wire at the distal broken end was found to be exposed.No other anomalies were observed.Testing/analysis: the usable length of the echelon-10 micro catheter was measured to be within specifications.The catheter was flushed with water and found to be patent.The catheter was then tested by running an in-house 0.016 mandrel through catheter hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.Conclusion: the returned echelon 10 was found damaged.The distal tip and marker band were separated and missing.The outer and inner tubing material at the broken end exhibited with jagged edges and stretching.The inner elliptical wire at the distal broken end was found to be exposed.In addition, the catheter body was also found to be kinked at several locations.However, the cause for the separation and damages could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.The event is related to regulatory report: 2029214-2022-00472.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 an axium prime coil became stretched and prematurely detached.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the posterior communicating artery.The max diameter was 6mm, and the neck diameter was 3mm.The patient's vessel tortuosity was normal.The access vessel was the femoral artery.It was reported that in the process of pushing the coil, when adjusting the position of the coil, the coil was stretched and broke/prematurely detached.A solitaire stent was used to grab the spring wire.The coil and the microcatheter were replaced.The pushwire was not bent or broken, and there had been no friction/difficulty during delivery.The coil had been repositioned 3 times.No detachment attempts had been made.The physician did not rotate the delivery pusher during the procedure, and a continuous flush had been administered. when grasping for the stretched spring coil, the internal carotid artery appeared dissected.No additional medical or surgical intervention was required, and the patient did not experience any injury. the devices were prepared and flushed according to the instructions for use (ifu).Additional information received reported that there were no issues that resulted in the damage that was found.

• 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: 14866569
• MDR Text Key: 301645314
• Report Number: 2029214-2022-01083
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: 00847536005969
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B277161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Date Device Manufactured: 10/06/2021
• 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: 55 YR
• Patient Sex: Female