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

Model Number	M3-1430
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following reported information: the device was inserted over a pilot 200 through a chronic total occlusion (cto) of the left artery descending (lad) that was heavily calcified.The lesion was treated with a 1.5 takeru before insertion of the m3.The m3 did not make it all the way down the vessel.After manipulation of the m3, it appeared that a portion of the tip of the m3 broke off and was in the vessel.Multiple micro catheters, wires, and balloons were used to open the lesion.The patient will be brought back in 2-4 weeks to cover the tip with a stent.It was believed the tip is in the sub intimal space of the lad.The blood loss was less than 250cc.The patient was stable.The device was not contaminated by infectious agents or anti-cancer agents.

• Brand Name: FINECROSS
• 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: 24379862
• Report Number: 2243441-2026-00005
• Device Sequence Number: 10490580
• Product Code: DQY
• UDI-Device Identifier: 04987892058875
• UDI-Public: (01)04987892058875(17)261231(10)250131
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026
• Report Date (Section F): 02/18/2026

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: M3-1430
• Device Catalogue Number: NC*A853B
• Device Lot Number: 250131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2026
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• 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; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/18/2026