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	01/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id ped2-400-18 (unknown).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
It was reported that during an intracranial aneurysm procedure treated with pipeline implantation using the marksman catheter 150cm, catheter resistance was encountered at the distal end.After successful stent deployment, the stent push rod distal end could not be withdrawn into the catheter, resulting in the tip radiopaque marker wire and protective sleeve remaining outside the catheter.The operator was required to remove both the catheter and push rod together, and because the push rod could not be fully withdrawn, its distal part remained outside the catheter and interfered with the stent tip during system removal.This interference caused the stent tip to shift downward by approximately 3 millimeters.The operator had anchored the stent sufficiently high, so after the shift, the stent distal end maintained a 4 millimeter anchoring distance from the aneurysm outflow tract.The access vessel was the right femoral artery with a diameter of 7.6 millimeters, and vessel tortuosity was normal.The catheter and accessory devices were prepared and flushed as indicated in the instructions for use.No patient complications or injuries have been reported as a result of this event.
Event or Problem Description
Additional information was received reporting that the cause of the event was not determined.Continuous saline flush was administered and maintained as indicated in the ifu.There was no observed damage to the pipeline pushwire or catheter.
Additional Manufacturer Narrative
B5: additional information added to event summary.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
H2/h3: product analysis as found condition: the marksman catheter was returned for analysis inside the biohazard bag, and shipping box.The pipeline flex shield delivery system was not returned.Damage location details: the catheter tip and marker were examined; no damage was found.The catheter body appeared to be flattened between 3.2cm and 19.0cm from the distal tip.No flash or voids molded were observed in the hub.No other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured to be 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 analysis findings, the customer complaint was confirmed as the returned catheter was found to be flattened.Possible resistance causes include vessel tortuosity, and lack of continuous flush during delivery.However, the customer indicated that the vessel tortuosity was normal and a continuous flush with heparinized saline was used, which rules them out as potential causes.However, the cause of the resistance could not be determined.Since the pipeline flex shield delivery system was not returned, any contribution of it made to the resistance issue could not be determined.Ls 2026-02-20 h6: updated codes from product analysis.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: 24037263
• Report Number: 9617601-2026-00222
• Device Sequence Number: 9074977
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: (01)00847536026261(17)270624(10)229149625
• 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): 03/03/2026

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: 229149625
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 01/14/2026; 02/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/04/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 44 YR
• Patient Sex: Male