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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of gwa.014 involved broke off in a very heavy calcified area of the posterior tibial artery.The wire was being used through a finecross m3.When pushed multiple times into the calcified segment, the wire tip broke.The case was completed as normal, and the piece of wire was not removed as it was not causing any issues with the patient.The patient condition was not affected.The procedure outcome was not affected.The event occurred intra-operative.There was no medical or surgical intervention required.Additional information was received on 08 dec 2022: the case was a cli case for a non-healing wound on the patient's heel.There was no blood loss.The patient was in stable condition and was not affected; however, the tip of the wire was left behind.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18219267
• Report Number: 2243441-2022-00034
• Device Sequence Number: 12442926
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: 04987350717924
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2023
• Report Date (Section F): 11/28/2023

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: GA1430
• Device Lot Number: 220914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 11/28/2023