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); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a pipeline flex stent could not be opened.After several attempts, the stent could no longer be retrieved or deployed.Damage to the marksman catheters was suspected, so it was removed.The stent and marksman catheters were replaced with medtronic products to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing dense mesh flow diversion surgery for treatment of an unruptured, fusiform, right vertebral artery v4 with a max diameter of 6 mm and a 5 mm neck diameter.The landing zone arterial diameter was 4.2 mm distally and 4.7 mm proximally.Femoral artery access vessel diameter was 9 mm.It was noted the patient's vessel tortuosity was minimal-moderate.The patient has a history of hypertension.Dual antiplatelet treatment (dapt) was administered.The platelet reactivity unit (pru) level was noted as meeting standards.The angiographic result post procedure showed smooth blood flow.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).Ancillary devices included a navien rfx058-115-08 intracranial support catheter.
Additional Manufacturer Narrative
Continuation of d10: pipeline flex stent product id: ped-500-30 (d020152).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
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.Vessel tortuosity was confirmed as moderate bending.Both the stent and marksman catheters were removed from the patient; only one marksman catheter (pli20) was used with the same stent, with the same complaint reported for both.The causes of the stent failure to open and the inability to deploy or retrieve the stent were not determined.Suspected blood vessel tortuosity and damage caused by retrieval were considered as possible causes for the suspected marksman catheter damage.The distal section of the pipeline did not open, and the device had not been placed in a vessel bend at the time of failure.Resheathing was attempted, and high resistance was encountered during delivery, specifically in the distal section of the catheter.The catheter was flushed according to the ifu during the procedure.
Additional Manufacturer Narrative
Product analysis ¿ as found condition: the pipeline flex device and marksman catheter were returned for analysis inside a sealed biohazard bag and inside a shipping box.¿ damaged location details: the pipeline flex tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were intact, with no damage noted.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation or damage.The pusher wire was kinked at ~88.5cm from the distal tip and at ~21.5cm from the proximal end of the pusher wire.The braid was already detached from the pusher wire when it was returned; therefore, the distal and proximal ends could not be identified.Both braid ends were open and frayed.The braid¿s middle section was fully open but damaged.The marksman catheter tip and marker were examined, and no damage was noted.The catheter body was in good condition.No voids or flashes were found on the catheter hub.No other anomalies were found.¿ testing/analysis: the marksman catheter total and usable lengths were measured within specifications.The catheter was flushed with water and was found patent.The catheter was tested by running an in-house 0.026-inch mandrel through the hub and tip without issues.¿ conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ report could not be confirmed, as both ends of the returned pipeline flex braid ends were open and frayed.However, the cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, an improperly sized braid to the anatomy, an overstretched braid during delivery, the user deploying the braid in the vessel bend, or a damaged braid.In this event, the customer reported that the vessel tortuosity was moderate, and the pipeline had not been placed in a vessel bend, ruling out vessel tortuosity and the user deploying the braid in the vessel bend as possible causes.Therefore, an improperly sized braid to the anatomy, an overstretched braid during delivery, and a damaged braid could have contributed to the failure to open.The braid can be damaged due to over-manipulation, re-sheathing more than twice, deployment techniques, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing against resistance.However, the cause of the braid damage could not be determined.In addition, the damage seen on the braid (fraying) and pusher wire (kinked) could indicate that high force was used.The damage may have occurred when the user attempted to advance or retrieve the pipeline flex through the marksman catheter against resistance.Possible causes of resistance include frayed ends on the braid, the user pulling back on/torquing the wire while advancing the ped in the catheter, and a lack of continuous heparinized saline flush during the procedure.During this event, the customer stated that the catheter was flushed according to the ifu during the procedure, ruling out a lack of continuous heparinized saline flush during the procedure as a possible cause.Therefore, frayed ends on the braid, and the user pulling back on/torquing the wire while advancing the ped in the catheter could have contributed to the reported resistance.However, the cause of the resistance could not be determined.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: 23452205
• Report Number: 9617601-2025-02459
• Device Sequence Number: 7968969
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: (01)00836462014077(17)270802(10)229379785
• 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): 01/30/2026

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: 229379785
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 01/27/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 60 KG