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

Catalog Number	N141802
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/08/2019
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
The physician was intending to use a nitrex guidewire to treat a 210mm severely calcified cto in the right distal tibial/popliteal trunk and posterior tibial artery.Moderate tortuosity was reported and the artery diameter was 3mm.A non medtronic 7fr 23cm sheath and a 0.014 x 180cm guidewire were used in the procedure.The vessel was predilated.The ifu was followed and the device was prepped with no issues.It was reported that the tip of the guidewire detached from the wire at the target lesion when the physician tried to remove the device from the artery.The physician attempted to retrieve the detached part using a 7fr 120cm snare but could not remove it from the patient.The tip remains inside the patient at the distal posterior tibial artery.
Additional Manufacturer Narrative
Additional information: completion of arteriogram revealed no vascular deficit in the area of cto posterior tibial.Collateral circulation was noted satisfactory.Treatment for the condition, plavix and atorvastatin.The patient does not present symptoms related to the event.The physician is not planning to perform any more procedures to remove the tip from the tibial artery.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: 8435610
• Report Number: 2183870-2019-00136
• Device Sequence Number: 2242332
• Product Code: DQX
• UDI-Device Identifier: 00821684058114
• UDI-Public: 00821684058114
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 09/01/2021
• Device Catalogue Number: N141802
• Device Lot Number: 11057694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: 48 YR
• Patient Weight: 57