MAUDE Adverse Event Report: MEDTRONIC IRELAND ARES¿; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	95001
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis determined that the visual and optical inspection did reveal some red coloring at the end of the catheter.The color may have been a result of the catheter soaking in the solution.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 information regarding a catheter.It was reported that during a ventriculoperitoneal shunt placement and during the site's preparation, when the catheter was soaked in an antibiotic solution, the site noticed one of the ends of the catheter started to turn yellow.It was clarified that it wasn't quite yellow but a red.The distal portion did not have the same discoloration.It was unknown if the catheter came that way or if it was because it was soaked in vancomycin saline.The site switched to another catheter and was able to continue.The situation could not be replicated with the new catheter.

• Brand Name: ARES¿
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 22939480
• Report Number: 9612164-2025-04327
• Device Sequence Number: 9878727
• Product Code: JXG
• UDI-Device Identifier: 00643169762664
• UDI-Public: (01)00643169762664(17)261008(10)0012754162
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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
• Device Model Number: 95001
• Device Catalogue Number: 95001
• Device Lot Number: 0012754162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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
• Patient Sex: Unknown