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

Model Number	FA-55160-1030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the marksman microcatheter was being used with an embotrap device.Upon the third retrieval, it was noted the distal portion of the marksman microcatheter had fractured.There had not been any resistance experienced, there was no vasospasm, and no medical or surgical intervention required.The fractured portion was on the embotrap, and so the embotrap was safely removed containing both pieces.A new marksman microcatheter was used to complete the case with no further issue reported.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a stroke thrombectomy.It was noted the patient's vessel tortuosity was moderate.
Additional Manufacturer Narrative
H3: analysis of the marksman microcatheter (lot no.221330615) found that no damages or irregularities with the marksman hub.The marksman catheter was found broken at ~142.3 cm from the proximal end.The distal segment was found to be ~29.4 cm.The total length is therefore ~171.7 cm, and the usable length was measured to be ~164.0 cm which is no longer within specification (specification: total = 167 cm ±3 cm, usable: 160 cm ±3 cm).The tubing material of the marksman catheter separated end exhibited with stretching and jagged edge.The inner coil wire was found exposed, and the inner liner found stretched at the break.The distal ~2.3 cm of the proximal segment, and the proximal section of the distal segment were found stretched, flattened, and accordioned.No damages or irregularities were found with the distal tip and marker band.Dried blood was found within the micro catheter.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed, however the cause could not be determined.The broken end of the marksman catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.Possible causes of failure are user advances/retrieves intraluminal device against resistance, vasospasm, patient vessel tortuosity, entrapment in vessel, more than 20 cm of the traction was applied, fast catheter retrieval technique or user applies excessive force.Customer reported no resistance encountered, no vasospasm, devices were prepared per ifu, and patient vessel tortuosity was moderate.As the embotrap revascularization device used in the event was not returned, any contribution of the embotrap towards the catheter break could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The catheter total and usable length was measured above specification, likely due to the stretching found at the location of the break.There was no indication that the event was related to a potential manufacturing issue.H6: method code updated to b01.Result code updated to c070601 and c070603.Conclusion code updated to d15.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: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11769688
• Report Number: 2029214-2021-00527
• Device Sequence Number: 17204584
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: 00847536026278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2023
• Device Model Number: FA-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: 221330615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1