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	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the glidewire gold broke off inside the patient.They were able to retrieve the tip out of the patient.There was calcium in the patient's artery, and the way the wire was manipulated caused it to break off.There was no estimated blood loss.There was no surgical intervention required.There was no direct allegation that the reported device caused or contributed to patient injury.Additional information was received on 30oct2023: the procedure was a peripheral.A snare was used to remove the broken tip.

• 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: 18148621
• Report Number: 2243441-2023-00041
• Device Sequence Number: 7609184
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2023
• Report Date (Section F): 11/16/2023

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: GM1831
• Device Lot Number: 221213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• 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; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/16/2023