MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-5211
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received an fda uf/importer report # (b)(4).The event description states: during a stent/angioplasty procedure, part of a guide wire sheared off in the aorta.The remnants of the wire were successfully snared and retrieved.There was no harm to the patient.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 21050639
• Report Number: 2243441-2024-00044
• Device Sequence Number: 9645142
• Product Code: DQX
• UDI-Device Identifier: 04987350734709
• UDI-Public: (01)04987350734709
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/01/2025
• Report Date (Section F): 01/01/2025

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: 25-5211
• Device Catalogue Number: 25-5211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/01/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2025