MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55150-1030
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that initially, a marksman microcatheter was selected for the deployment of a 4.5-18 stent.During the process of retracting the rivet to deploy the stent, after the stent was fully apposed at the bifurcation and when performed passing the bending operation and increased tension, the operator found that the stent could be deployed normally but could not be completely retrieved.The stent became stuck at the tip of the microcatheter and could not be retrieved despite repeated attempts.This also caused displacement of the stent tip.When the operator tried to fully withdraw the stent back into the microcatheter, the stent tip remained stuck at the microcatheter tip and could not be removed.Therefore, the entire system was withdrawn from the body, and a new p27 microcatheter and 4.25-18 stent were used to repeat the procedure.The surgery was completed successfully.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing intracranial aneurysm embolization, dense mesh stent implantation of a saccular, unruptured terminal internal carotid artery aneurysm with a max diameter of 3.2mm and a 3.15mm neck diameter.Landing zone: distal: 3.22mm and proximal: 4.34mm.It was noted the patient's vessel tortuosity was normal.Access vessel was the femoral artery with an 8mm diameter.It was unknown if dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed the blood vessels were unobstructed with no abnormalities.
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
Update to h6: a0509 was updated to a0510.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
Additional information was received stating that the cause of the event was not determined.Resistance occurred in the tip end.No damage to the pipeline pushwire or catheter was observed.Multiple pipeline devices were not being used when movement occurred.There was no friction or difficulty during delivery or positioning.The pipeline was implanted at the intended location.The device did not jump during deployment.The tip of the catheter was not moved during deployment.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the pipeline flex, stuck inside the distal tip of the marksman catheter, was returned inside a bio-hazard bag and a shipping box.¿ damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The braid's distal and proximal ends were found open and frayed.No bend was found on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, resheathing pad, or the proximal bumper.The catheter tip and marker were examined, and no damage was found.The catheter body was found to be accordioned at 10.0cm to 20.0cm from the distal tip.No other anomalies were observed.¿ testing/analysis: the pipeline flex was pushed out from the catheter lumen with difficulty.The total and usable length were measured within specifications.The catheter was flushed with water and found patent.It was then tested by running an in-house 0.026¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub without issues; however, resistance was observed at the damaged locations.¿ conclusion: based on the returned devices, the customer report of "resistance during retrieval" was confirmed, as the pipeline flex was returned stuck inside the distal tip of the marksman catheter.The observed damage to the catheter (accordioning), braid (fraying), and hypotube (stretching) indicates that a high force was likely applied.This damage may have occurred when the customer attempted to advance/retrieve the pipeline flex through the catheter against resistance.Possible causes of the resistance include vessel tortuosity and a lack of continuous flush with heparinized saline during delivery.However, the customer indicated that vessel tortuosity was normal, ruling it out as a potential cause.In this event, a lack of continuous flush with heparinized saline contributed to the resistance during delivery.The customer report of "movement during deployment" was not confirmed.The cause could not be determined.Possible causes of movement during delivery include vasospasm and excessive force.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 ; 7635265677
• MDR Report Key: 23522758
• Report Number: 9617601-2025-02624
• Device Sequence Number: 10097742
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: (01)00847536026261(17)270520(10)228916929
• 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): 01/28/2026

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: 228916929
• 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: 11/09/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 01/16/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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: 67 YR
• Patient Sex: Female