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	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the tip end of the solitaire ab stent became damaged and resistance was encountered.The patient was undergoing surgery for treatment of an amorphous, unruptured right c5 aneurysm with a max diameter of 6 mm and a 3 mm neck diameter.The landing zone was 4 mm distally and 4.5 mm proximally.It was noted the patient'sblood flow was normal and vessel tortuosity was normal.The patient's medical history was that they were previously in good health.It was an aneurysm without stroke.It was reported that a c5 aneurysm embolization was performed.The aneurysm had an irregular shape and required stent-assisted embol ization.A solitaire ab stent was used and delivered to the aneurysm neck, but the initial position was unsatisfactory.When attempting to retrieve and reposition the stent, resistance was encountered.The stent was retrieved into the microcatheter but could not be withdrawn, so both the stent and the microcatheter were removed together.It was found thatthe tip of the stent was fractured.The procedure was completed successfully after replacing both the stent and the microcatheter.There were no patient symptoms or complications associated with this event.The device and any accessories were prepared as indicated in the instructions for use.Additional information received reported that the cause of the event was not determined.The microcatheter was a medtronic device.The¿resistance was located in the distal catheter.There was no kink or damage on the catheter.The catheter flush was administered per ifu during the procedure.The stent was not positioned in a bend.It was clarified that the tip of the stent was fractured.
Additional Manufacturer Narrative
Continuation of d10: solitaire stent product id sab 6-30, lot b818739 g4: pma unknown as catheter model and lot are unknown at this time 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: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 reporting that the tip of the solitaire sheath was secured into the hub of the microcatheter.
Event or Problem Description
Additional information was received.There was no kink or damage to the pushwire of the solitaire; however, damage was observed at the distal end of the stent body, and the device has been returned.
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.

• 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 CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24278336
• Report Number: 2029214-2026-00238
• Device Sequence Number: 13243474
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: (01)00847536026261(17)270605(10)229008946
• 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): 03/27/2026

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: 229008946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/05/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/05/2026; 03/30/2026
• Date Device Manufactured: 06/05/2024
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 58 KG