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

Model Number	N181804
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was using nitrex guide wire during procedure.It was reported that the wire tip detached in the vessel (in vivo).Another wire was used to complete the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NITREX NITINOL GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9553779
• Report Number: 2182208-2020-00016
• Device Sequence Number: 2133870
• Product Code: DQX
• UDI-Device Identifier: 00821684058176
• UDI-Public: 00821684058176
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2020

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 Expiration Date: 12/01/2021
• Device Model Number: N181804
• Device Catalogue Number: N181804
• Device Lot Number: 11104556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 01/31/2020; 02/12/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/07/2020; 02/03/2020; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1