MAUDE Adverse Event Report: MEDTRONIC MEXICO MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55150-1030
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received a report that the stent could not be detached.The physician attempted to detach the stent with the detachment box 3 times.Each attempt was 2.The condition of the detachment box and detachment cables was brand-new out of box.There was no damage to the detachment box.The catheter tip was located standard operation from the detachment zone during the detachment attempt.The detachment zone was not up against the vessel wall.A steel needle was used during the detachment.The needle was placed in muscle layer.The physician used a new battery during the detachment.The detachment box display as indicated in the instructions for use (ifu).The black cable was connected to the needle.The red cable was connected to the pusher wire.The pushwire was on a dry, clean surface.Additionally, the catheter tip was damaged (kinked) and unable to deliver.The damage was the distal section.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient was undergoing large artery occlusion embolectomy surgery for treatment ischemic stroke located in the middle cerebral artery.It was noted the patient's blood flow was xxx and vessel tortuosity was severe.Iv tissue plasminogen activator (tpa) was not contraindicated.There were two passes with the device.The access vessel was the femoral artery with a diameter of 20 mm.
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.
Additional Manufacturer Narrative
H3: product analysis as found condition: the marksman catheter was returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the marksman catheter tip and marker were examined and were found flattened.The catheter body was flattened at 1.5cm from the distal tip and was kinked at 21.5cm to 23.0cm from the distal tip.No flashes or voids were noted on the catheter hub, and no other anomalies were found.Testing/analysis: the marksman catheter¿s total and usable lengths were measured within specifications.The catheter was flushed with water and found patent.The catheter was tested by running an in-house 0.026-inch mandrel through the hub without issues; resistance was observed along the damaged locations.Conclusion: based on the reported information and device analysis, the customer¿s ¿catheter resistance¿ complaint was confirmed, as the returned marksman catheter was damaged (flattened and kinked).The damage likely occurred when the customer attempted to advance the solitaire device through the marksman catheter against resistance.However, the root cause of the resistance failure could not be determined.Possible causes include severe vessel tortuosity, incompatible or damaged devices, a low flush rate, or a lack of co ntinuous flush with heparinized saline during delivery.In this event, the marksman catheter is compatible with the solitaire device, ruling out incompatibility as a potential cause.Therefore, severe vessel tortuosity, damaged devices, a low flush rate, or a lack of continuous flush with heparinized saline during delivery could have contributed to the resistance failure.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; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21707899
• Report Number: 9617601-2025-00301
• Device Sequence Number: 11961289
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• 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,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 228359682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 05/08/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 71 KG