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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that upon advancing the guidewire involved, the tip broke off at an occluded area of the vessel.The doctor determined it was best to leave the tip in the patient.The patient was in stable condition and the procedure outcome was fine.There was no patient injury/medical or surgical intervention required.Additional information was received on (b)(6) 2023: the doctor was doing routine work.The doctor reported that he was not tugging or pushing hard.The procedure was an angiogram of the leg, and the wire broke in the popliteal area.There was calcification and the doctor was trying to cross the lesion; however, the doctor did not do anything out of the ordinary, and it was not in very long, only a few minutes.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16938761
• Report Number: 2243441-2023-00020
• Device Sequence Number: 15316269
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: 04987350711908
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2023
• Report Date (Section F): 05/16/2023

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: GM1831
• Device Lot Number: 220620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• 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: 05/16/2023