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

Model Number 145-5091-150

Device Problems Break (1069); Unintended Movement (3026)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

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 echelon 10 was shaped and brought into the aneurysm with a guide wire.A coil was used, but the echelon 10 was unstable when forming a hoop and the echelon 10 was withdrawn.At this time, the physician noted breaks and gaps at the tip of the echelon 10 and the physician replaced the echelon 10 was replaced for another echelon 10 of the same model.The procedure was completed successfully.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 treatment of a left ophthalmic artery aneurysm with a max diameter of 6.8mm and a 6.3mm neck diameter.The access vessel was the femoral artery with a diameter of 4.8mm.It was noted the patient's vessel tortuosity was normal.

Manufacturer Narrative

H3.Product analysis: equipment used: vis (m-81805) s found condition: the echelon-10 catheter was returned for analysis within a shipping box, a plastic bio-pouch, and its protective tray.Damage location details: no damages were found with the echelon-10 catheter hub.No bends or kinks were found with the echelon-10 catheter body.However, the echelon-10 catheter distal tip was found bent.The characteristics of the bent catheter distal tip are consistent with tip shaping.The catheter tubing at the proximal edge of the distal marker was found damaged.Upon microscopic inspection, a hole/puncture was found in the catheter tubing at the proximal edge of the distal marker.Testing/analysis: none conclusion: based on the device analysis and reported information, the customer¿s report was confirmed.The catheter can become damaged (hole/puncture) if an intraluminal device is navigated within the catheter aggressively, if the guidewire is inserted without checking catheter integrity/catheter patency, or if the distal tip is shaped improperly.However, the cause of the catheter damage could not be determined.Catheter kickback can occur due to patient vessel tortuosity, high friction, user advances or retrieving intraluminal devices against resistance, vasospasm, irregular blood flow, catheter tip under stress during the event, or incompatible ancillary devices.However, the cause for the catheter kickback could not be determined.H6.Coding updated based on analysis results.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: 17704502
• MDR Text Key: 323324621
• Report Number: 2029214-2023-01616
• 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,Followup
• Report Date: 12/06/2023

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 Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B523205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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: 69 YR
• Patient Sex: Female