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

Model Number	NC35901
Medical Device Problem Codes	Material Separation (1562); Unintended Deflation (4061)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: the product was used during a trans jugular intrahepatic portosystemic shunt (tips) procedure with a navicross catheter over a 0.035'' amplatz wire to access the portal vein.During withdrawal, resistance was encountered and the distal tapered tip of the navicross catheter became lodged.Upon further retraction, the catheter separated at the distal end.This event occurred outside the patient, and the detached segment was retrieved without complication.There were no adverse effects to the patient, and the procedure was completed successfully.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 24304902
• Report Number: 2243441-2026-00003
• Device Sequence Number: 18557007
• Product Code: DQY
• UDI-Device Identifier: 04987350709189
• UDI-Public: (01)04987350709189(17)280430(10)250520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2026
• Report Date (Section F): 02/10/2026

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: NC35901
• Device Catalogue Number: WS*NA35093H
• Device Lot Number: 250520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2026
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• 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: .035 260CM AMPLATZ WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/10/2026