MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO NAVICROSS SUPPORT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC,

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that one of the radiopaque markers of the navicross catheter came off during the procedure and traveled down to the superficial femoral artery.The physician was able to trap it with a stent.Fluoroscopy video was available.The marker was stented against the vessel intima.The procedure was successful, and the patient was discharged.Additional information was received on 07 feb 2023: the procedure performed was a popliteal artery angiogram.There was no blood loss.The patient was successfully treated, stable and discharged.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC,
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16479208
• Report Number: 2243441-2023-00010
• Device Sequence Number: 3150389
• Product Code: DQY
• UDI-Device Identifier: 04987350709189
• UDI-Public: 04987350709189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/03/2023
• Report Date (Section F): 03/03/2023

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: NC35901
• Device Lot Number: 220728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/06/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COVERED STENT; DESTINATION SHEATH; GLIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/03/2023