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); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the marksman catheter was used to deliver a pipeline flex flow diversion stent.After the stent was successfully placed in position and deployed, the stent delivery system push rod could not be inserted (retracted) into the catheter; the small wings at the distal end of the push rod were stuck at the distal end of the catheter.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 mm.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).Additional information was received.The aneurysm was in the right ophthalmic artery segment, approximately 5x4x3.4 mm.The operator suspected that the small wing of the push rod was stuck in the distal end of the catheter and the push rod could not be retracted after the stent was deployed.An attempt was made to retract the push rod into the catheter was unsuccessful, therefore, the entire push rod and catheter were withdrawn from the body, and then the catheter was reinserted to continue the surgery.The cause of the resistance was not determined.Continuous saline flush was administered and maintained as indicated in the ifu.No damage to the pipeline pushwire or catheter was observed.
Additional Manufacturer Narrative
Continuation of d10:pipeline flex stent model ped-425-16, lot number d048268.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 pipeline was successfully deployed, and there was no complaint regarding the stent itself.However, after stent deployment, the pushrod could not be retrieved into the marksman, which increased the difficulty of the procedure.
Additional Manufacturer Narrative
Updated b5, d9.H3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event.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 pipeline flex pushwire and marksman catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex pushwire was returned within the marksman catheter.The pipeline flex braid was not returned for analysis.Therefore, any contributing factors could not be assessed.¿ damage location details: the pushwire extending out from catheter hub.In addition, the sleeves and tip coil were deployed from catheter distal tip.No bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The dps sleeves were found intact with no signs of damage.No defects were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper and tip coil.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 marksman catheter tip and marker were examined; and no damage was found.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.¿ conclusion: based on the analysis findings, the pipeline flex and marksman catheter could not be confirmed to have resistance as no defect were found with the pipeline flex pushwire and marksman catheter.No resistance was observed during testing.Possible causes include incompatible catheter, damaged catheter, burrs, bumps, kinks or other damage on ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, and users pulls back on/torques wire while advancing ped in microcatheter.The marksman catheter is compatible to use with pipeline flex, the patient's vessel tortuosity was normal, and the catheter was continually flushed with heparanized saline as indicated in 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: 23663098
• Report Number: 9617601-2025-03062
• Device Sequence Number: 8910165
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: (01)00847536026261(17)270814(10)229480132
• 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): 01/23/2026

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: 229480132
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 01/05/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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: 65 YR
• Patient Sex: Female