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

Catalog Number	N180802
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/21/2019
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
It was reported that a nitrex guidewire was being used in a procedure but the wire 'formed a knot' in the vein.When attempting to remove this wire, it was reported that part of it sheared off and had to be extracted.
Additional Manufacturer Narrative
Medwatch report number: (b)(4) additional information: during a procedure to place an implantable cardiac defibrillator, the physician used a micropuncture needle to access the left subclavian vein.The nitrex wire was used through a non-medtronic needle.It is reported the wire formed a knot in the vein.The physician successfully extracted two pieces of the wire and a final fluoro image was obtained to confirm the wire was completely removed.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): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8643973
• Report Number: 2183870-2019-00310
• Device Sequence Number: 11572343
• Product Code: DQX
• UDI-Device Identifier: 00821684058169
• UDI-Public: 00821684058169
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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 Expiration Date: 11/01/2021
• Device Catalogue Number: N180802
• Device Lot Number: 11090825
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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 Age: 66 YR
• Patient Weight: 71