MAUDE Adverse Event Report: MEDTRONIC, INC. (COVIDIEN LLC) NITREX NITINOL GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number	N183002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of a moderately calcified lesion in the mid right superficial femoral artery, wire damage/fraying was observed with the nitrex guidewire.A 7x45 non-medtronic sheath and an embolic protection device were used.The vessel was post-dilated.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Nothing detached off the nitrex guidewire and no intervention was required for removal of the device.The device was safely removed from the patient.A new product was not required as the case was completed.No patient complications have been reported as a result of 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.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: NITREX NITINOL GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC. (COVIDIEN LLC); 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): MEDTRONIC, INC. (COVIDIEN LLC); 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24257899
• Report Number: 2183870-2026-00051
• Device Sequence Number: 18116265
• Product Code: DQX
• UDI-Device Identifier: 00763000185459
• UDI-Public: (01)00763000185459(17)280801(10)9946247
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K040345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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 Catalogue Number: N183002
• Device Lot Number: 9946247
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 08/02/2025
• 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