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

Model Number	NC35131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: during a peri-valvular leak case, the navicross was pushed through the leak, behind the valve and into the left ventricle.The wire was exchanged for a safari wire.The navicross was pulled to be removed from the body.There was some difficulty pulling the navicross out.After removal, it was noticed that a marker band was left on the wire.Attempts to snare it out were made.Eventually the marker band ended up in the ventricle behind some papillary muscle.The patient will be brought back in a few weeks to attempt closure of perivavular leak again.The estimated blood loss was less than 250cc.Additional information was received on 04feb2026:sl: the patient was stable, and there was no harm to the patient.

• 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: 24492480
• Report Number: 2243441-2026-00008
• Device Sequence Number: 21504062
• Product Code: DQY
• UDI-Device Identifier: 04987350709202
• UDI-Public: (01)04987350709202(17)271231(10)250123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/02/2026
• Report Date (Section F): 03/02/2026

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: NC35131
• Device Catalogue Number: WS*NA350N3H
• Device Lot Number: 250123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2026
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• 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: 03/02/2026