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

Model Number 105-5056

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a patient underwent an arteriovenous fistula (avf) embolization procedure on (b)(6) 2019.During the procedure, the marathon microcatheter was entrapped could not be removed and was left in the patient's body.It was noted the device was prepared and flushed according to the instructions for use.On (b)(6) 2021, the patient presented with lower extremity pain that had existed for 2 weeks, and worsened for 1 week.Diagnostic imaging showed a dense shadow in the lower segment of the right femoral sign artery/popliteal artery/peroneal artery and foreign body was considered.The patient was transferred to hospital for further treatment.

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

Additional information was received on 2021-sep-03.It was reported that actions/interventions included diagnosis and treatment of vascular surgery in other hospital.The cause of the catheter separation was not determined.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12415065
• MDR Text Key: 269578907
• Report Number: 2029214-2021-01106
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: 00847536005914
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: A659526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR