MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA NAVICROSS; CATHETER, PERCUTANEOUS

Model Number	NC35131
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor performed an intervention and angioplasty on the distal superficial femoral artery (sfa), popliteal, and tibial arteries.There was a very tight lesion that presented difficulties in crossing, and she used the.035x135 angled navicross aggressively, along with various wires.The distal radiopaque marker of the navicross detached from the catheter and lodged in the distal anterior tibial artery.This did not obstruct blood flow, and the physician decided not to remove it.The procedure performed was a right leg peripheral arterial disease (pad) intervention, with no blood loss reported.The incident occurred intra-operative.The reported incident did not result in patient injury or medical or surgical intervention.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 20058007
• Report Number: 2243441-2024-00024
• Device Sequence Number: 15618775
• Product Code: DQY
• UDI-Device Identifier: 04987350709202
• UDI-Public: 04987350709202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2024
• Report Date (Section F): 08/23/2024

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 Model Number: NC35131
• Device Catalogue Number: WS*NA350N3H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/23/2024