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

Model Number	RF*GA35353P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved radifocus was used during the procedure.Part of the wire broke off in the patient during the procedure.They had to bring the patient back the next day to remove the broken piece.Additional information was received on 06jan2021.The procedure was a left upper extremity venogram.Angle glide wire 0.035 extravasated outside the vein with persistent twisting of the wire; the wire became caught an extra vascular tissue as the user tried to pull the wire the tip of it severed off.The user does not believe there was any issue with the wire itself.

• 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: 11193473
• Report Number: 2243441-2020-00069
• Device Sequence Number: 14422497
• Product Code: DQX
• UDI-Device Identifier: 04987350726421
• UDI-Public: 04987350726421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/19/2021
• Report Date (Section F): 01/19/2021

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: 03/31/2022
• Device Model Number: RF*GA35353P
• Device Catalogue Number: GR3535
• Device Lot Number: 200428
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/24/2020
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2021
• 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
• Date Report Sent to FDA: 01/19/2021