MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55150-1030
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received reporting that the patients vessel tortuosity was normal.The patient is recovering good.No patient symptoms or further complications were reported as a result of this event.The pipeline had not been placed in a vessel bend when it failed to open.No additional steps or other devices were attempted to open the pipeline.The inner liner coating was not observed to be from the marksman catheter.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; +1(763)526-5677
• MDR Report Key: 50278788
• Report Number: 9617601-2026-05160
• Device Sequence Number: 10267742
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: (01)00847536026261(17)280723(10)231791324
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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 Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 231791324
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown