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); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: pipeline flex with shield technology stent product id ped2-400-16 (lot d061108);  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 after the marksman catheter was in place, the pipeline flex with shield technology stent was delivered, and the stent deployment process was smooth.However, after deploying the stent and when retracting the stent delivery rod, the distal end of the delivery rod could not be retracted into the distal catheter, resulting in the distal radiopaque marker and protective sleeve being outside the catheter.At this point, the surgeon could only withdraw both the catheter and the delivery rod together.Upon removal from the body, it was found that the catheter was severely deformed, and the stent delivery rod was outside the catheter, affecting intraoperative manipulation.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an intracranial aneurysm.It was noted the patient's vessel tortuosity was normal.Right femoral artery access vessel diameter was 7.2 mm.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
Update b5 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.The patient was treated for ophthalmic artery aneurysm, 4.3 × 2.6 × 2 mm; irregular aneurysm, right side, 4.3 × 2.6 × 2 mm).The cause of the resistance was not determined, and the cause of the catheter damage was also not determined.A continuous saline flush was administered and maintained in accordance with the ifu.No damage to the pipeline pushwire was observed.
Additional Manufacturer Narrative
H3 product analysis: ¿ as found condition: the marksman catheter was returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield device used in this event was not returned for analysis.Therefore, any contributing factors could not be assessed.¿ damage location details: no flash or voids molded were observed in the hub.No damage was found with hub.No bent or kink was found with catheter body.The catheter tip and marker were examined; and was found to be flattened.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of marksman catheter were measured to be within specifications.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged location.¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter kink/damage¿ and ¿catheter resistance during retrieval¿ were confirmed as the catheter was found to be damaged.Possible causes include incompatible devices, patient vessel tortuosity, flush rate too low, catheter damage or device damage, guidewire or delivery system damage, material occludes catheter, insufficient catheter flushing or lack of continuous flush, insufficient guidewire or delivery system hydration.It was noted that it was noted the patient's vessel tortuosity was normal and a continuous saline flush was administered and maintained in accordance with the ifu.Which eliminates these factors out as potential causes.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: 24223810
• Report Number: 9617601-2026-00810
• Device Sequence Number: 21178421
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: (01)00836462014077(17)280606(10)231338909
• 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): 04/27/2026

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: 231338909
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 04/02/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/05/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 44 YR
• Patient Sex: Female