MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55160-1030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a marksman catheter leaked.The patient was undergoing intra-arterial therapy (iat).It was noted the patient's vessel tortuosity was normal.It was reported during the iat procedure, the physician performed a flushing test prior to using the marksman product and observed leakage.The device was then replaced with a new marksman160 of the same lot, and the procedure was successfully completed.The devices were prepared and flushed as indicated in the ifu.No patient symptoms or complications were associated with this event.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received; the device was flushed according to the correct procedure before the issue was identified.The device was not damaged out of packaging prior to flushing, and there was no damage or evidence of tampering to the device packaging.The exact cause of the leak was not determined at the time of the event, so the device was returned to the manufacturer for further inspection.Leakage was observed at the mid-to-distal section of the catheter.
Additional Manufacturer Narrative
Product analysis #(b)(4): ¿ as found condition: the marksman catheter and unknown guidewire were returned for analysis inside inner pouch, biohazard bag, and shipping box.The unknown guidewire appeared to be stuck inside the catheter.¿ damage location details: the catheter tip and marker were found to be flattened.The catheter body appeared to be flattened for the length of 7.0cm and accordioned at 27.0cm to 50.0cm from the distal tip.The catheter body was found to be partially separated at 29.0cm from the distal tip.Additionally, the catheter body was found to be accordioned at 7.0cm to 13.0cm from the proximal end of the catheter hub.No flash or voids molded were observed in the hub.The unknown guidewire was found to be kinked at 45.0cm and 77.3cm from the distal tip.No other anomalies were observed.¿ testing/analysis: the unknown guidewire was removed from the catheter lumen with difficulty.The distal, middle, and proximal of the guidewire were measured to be 0.013", which is compatible with the marksman catheter.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and found patent.The water was found leaking out from the separated location.¿ conclusion: based on the reported information and the device analysis, the customer¿s complaint was confirmed, as the water was found leaking out from the separated location.The observed damages to the catheter (accordioning/flattening), and guidewire (kinking) suggests that a high force was likely used.These damages may have resulted from the customer's attempts to advance or retrieve the guidewire through the catheter against resistance.However, the cause of the resistance could not be determined.Possible resistance causes include using a damaged device, and lack of continuous flush.The customer indicated that the vessel tortuosity was normal, which rules it out as a potential cause.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: 21925276
• Report Number: 9617601-2025-00432
• Device Sequence Number: 4085003
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: 00847536026278
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: 227958274
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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 Sex: Unknown