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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved glidewire advantage was used through a metal cystoscope during a cystoscope procedure.During withdrawal it was noticed that some of green/white portion of wire was shaved off.The reported event did not result in patient injury and/or require medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.No blood loss was reported.Additional information was received on 17apr2024: the green/white portion of the wire did shave off inside the patient.The shaved portion was removed through metal cystoscope.It was unknown if the patient had plaque or stenosis present.The patient was stable, and the procedure was completed successfully.

• 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: 19259115
• Report Number: 2243441-2024-00012
• Device Sequence Number: 6463734
• Product Code: DQX
• UDI-Device Identifier: 04987350703620
• UDI-Public: 04987350703620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2024
• Report Date (Section F): 05/07/2024

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: GA3501
• Device Lot Number: 231020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIGID CYSTOSCOPE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/07/2024