MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON 10 MICRO CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number 105-5091-150

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that a marker fell off the tip of the echelon microcatheter.The patient was undergoing surgery for treatment aneurysm with a an access vessel diameter of 8mm.It was noted the patient's vessel tortuosity was normal.It was stated all devices were prepared as per the instructions for use (ifu).It was reported that during treatment of aneurysms using the echelon as a device for the delivery of a spring coil, only one mark spot was seen through fluoroscopy when the microcatheter was in place.After taking it out, it was noticed the marker spot on the tip of the echelon had fallen off.The location of the missing echelon marker is not known.A new echelon was used to complete the procedure.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated as received, the echelon-10 total length and the useable length were measured found to be within specification.Upon visual inspection, no damages or irregularities were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.The echelon-10 distal marker/tip was found missing (separated) and missing segment was not returned.The whereabouts of the missing segment is not known.The distance from the distal edge of the proximal marker band to the distal separated end was measured, which is not within specification.Approximately 2.0mm of the distal marker band/tip was found missing.The outer and inner tubing material at the broken end exhibited with jagged edges and stretching.The inner elliptical wire at the broken end was found to be exposed.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿marker band dislodged¿ was confirmed.The broken end of the catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter tip separated when exceeding the tensile strength of the tubing material.It is possible high force was used (pushing/pulling) during delivery; subsequently causing the catheter tip to separate.However, the root cause for the tip separation could not be determined.The separated distal marker/tip was not returned; therefore, any contributing factors (such as damage) could not be assessed.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 10 MICRO CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9528257
• MDR Text Key: 209011713
• Report Number: 2029214-2019-01306
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: 00847536005969
• Combination Product (y/n): N
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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: 06/30/2021
• Device Model Number: 105-5091-150
• Device Lot Number: A857986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/08/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 79