MAUDE Adverse Event Report: COVIDIEN NITREX NITINOL GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number	N183002
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
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
It was reported that during treatment of a severe calcified lesion with 97% stenosis and 200 mm length in the proximal right anterior tibial artery, using the nitrex guidewire, wire damage occurred, including wire stripping and tip detachment at the target lesion.The tip was snared and removed.Severe resistance was encountered when advancing the device, but no excessive force was used.A 6fr non-medtronic sheath was used and the ifu (instruction for use) was followed during preparation, procedure, post-procedure.The vessel was post-dilated, and a new device was used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the image is a partial image of the pouch the lot number 9531842 can be seen on the label which is consistent with the complaint 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
I.

• Brand Name: NITREX NITINOL GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23002737
• Report Number: 2183870-2025-00434
• Device Sequence Number: 9090129
• Product Code: DQX
• UDI-Device Identifier: 00763000185459
• UDI-Public: (01)00763000185459(17)280301(10)9531842
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 11/17/2025

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 Catalogue Number: N183002
• Device Lot Number: 9531842
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 03/25/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown