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

Model Number	GM1811
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo guidewire glidewire used to advance through occluded tibial artery.In the process of removing the glidewire the tip broke off in the tibial artery.

• Brand Name: RADIFOCUS GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 10188471
• Report Number: 10188471
• Device Sequence Number: 908660
• Product Code: DQX
• UDI-Device Identifier: 04987350774194
• UDI-Public: (01)04987350774194(17)211231(10)200107
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020
• Report Date (Section F): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GM1811
• Device Catalogue Number: RF RA18183TA
• Device Lot Number: 200107
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/18/2020