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
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: staff interventional cardiologist.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.History investigation of the product with the involved product code/lot number - no anomaly was found in the manufacturing record and the shipping inspection record.- no other similar report was found in the past complaint file.Please refer to section h10 for the importer's report related to this event.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.Appearance confirmation of the actual device.- the second marker was missing.- a crimped mark was found at the position of the second marker.- no lifting or other anomaly was found in the third marker.- abrasion was found on the outer layer from the proximal side beyond the second marker to the crimped mark.This suggested that some kind of object had abraded the second marker from its proximal end toward the distal end.Dimensions of the actual device: - the outer diameter of the shaft: it met the factory's specifications.No anomaly was found.- the depth of the crimped mark (the difference between the outer diameter of the crimped mark and that of the adjacent part): it is equivalent to that of a current product which the second marker was taken out from.- no anomaly was found.No anomalies were found in the dimensions of the actual device.In addition, based on the investigation result 2, since the crimped depth was the same as that of the product of the involved product code/lot, it is inferred that the second marker was crimped normally.In this case, it was thought that the actual device was removed while in excessive contact with some object (such as a stenosis part) during use, which may have caused abrasions from the proximal end toward the distal end of the second marker, and the second marker to fall off.Ashitaka factory assures the quality of this product through the following work and controls.- the crimping of the markers is performed under the definite crimping conditions, with a core wire of controlled outer diameter inserted into the shaft.- the outer diameters of the shaft and of the marker after crimping are measured on 100% basis to ensure that the markers are crimped securely.- after the crimping process, a 100% electrical inspection of the markers is performed to detect any anomalies including cracks.The ifu of this product indicates as follows: - carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out the cause to avoid damage to blood vessels and separation or breakage of the product.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
Additional information was received on 03mar2026: the doctor confirmed they plan to leave the navicross marker alone and will relook at it when the patient gets a transcatheter aortic valve replacement.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24492481
• Report Number: 9681834-2026-00035
• Device Sequence Number: 10685192
• 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
• PMA/510(K) Number: K110540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown