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	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline tip failed to open and became stuck in the marksman and could not be withdrawn.The patient was undergoing surgery for treatment of a saccular, unruptured right internal carotid artery aneurysm with a max diameter of 4.75 mm and a 5 mm neck diameter.The distal landing zone was 4.75 mm and the poximal landing zone was 4.31 mm.The access vessel was the femoral artery with a diameter of 7 mm.It was noted the patient's vessel tortuosity was moderate/normal.Dual antiplatelet therapy (dapt) was administered and platelet reactivity units (pru) level was in the ideal range.The angiographic result post procedure was immediate aneurysm stasis.It was reported that the patient was diagnosed with a right internal carotid artery aneurysm and was scheduled to undergo transcatheter embolization of intracranial aneurysm.Intraoperative angiography showed that the patient was suitable for use of a flow-diverting mesh stent.Preoperatively, the flow-diverting mesh stent (model ped-475-16) was hydrated.Following routine operations, the stent was delivered to the target lesion vessel location.During the procedure, deployment of the tip end was not smooth; repeated attempts still failed to open it smoothly.It was planned to remove it from the body for inspection, and it was found that the stent was stuck inside the microcatheter and could not be withdrawn.Therefore, the microcatheter together with the stent was removed from the body.The new marksman microcatheter (fa-55150-1030) and the flow-diverting mesh stent (ped-475-16) were used instead for operations and the procedure proceeded smoothly.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an approved (on-label) indication.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.
Additional Manufacturer Narrative
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: 50872136
• Report Number: 9617601-2026-05760
• Device Sequence Number: 13106405
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: (01)00836462014077(17)280922(10)232166033
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 232166033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 09/22/2025
• 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 Age: 58 YR
• Patient Sex: Female