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

Catalog Number	N180601
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during placement of a line in the right internal jugular vein, challenging access required extensive guidewire manipulation and interventional radiology was requested to place the line.The lesion was fibrous.The patient had multiple upper extremity venous occlusions.Severe resistance was encountered during guidewire advancement, and excessive force was used.  a 035 angled non medtronic (glidewire) was advanced into the azygos vein and 5 french non medtronic (kumpe) catheter was advanced into the azygos vein.Central venous/azygous venography was performed confirming large caliber azygos venous collateral with brisk drainage into the ivc.Over a 027 guidewire, the 7 french non medtronic (arrow) triple-lumen central venous catheter was advanced and positioned in the cephalad aspect of the azygos vein.Contrast injected confirming appropriate location and brisk flow .The procedure was completed before a retained nitrex guidewire fragment was noticed. during the second advancement of the nitrex guidewire, the tip embolized into the vessel.Fluoroscopic imaging was used to localize the fragment.The overlying skin and deep soft tissue were anesthetized, a small incision was made, and pickups were used to engage and remove the guidewire fragment in its entirety.The patient was alive with no injury or health consequences reported.
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): 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 ; +353(091)708096
• MDR Report Key: 50560396
• Report Number: 2183870-2026-00418
• Device Sequence Number: 13385897
• Product Code: DQX
• UDI-Device Identifier: 00763000185374
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: N180601
• Device Lot Number: 10393516
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 02/02/2026
• 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: Female