MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; 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	07/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that something was noticed on the tech screen.The tip of the radifocus wire broke off in the patient.They checked the wire off the table; tip was split and the part that split broke off.There was no patient injury, medical/surgical intervention required.The patient's condition was stable.Additional information was received on 02aug2021.The procedure being performed was a left leg angiogram.The wire was located in the patients left lower leg/ sfa.The tip of the wire was not retrieved from the patient's body.There was no blood loss.Once the tip broke the procedure was perused with intentions to fix the distal occlusion, no success in getting pack the blockage; not due to the wire; due to the occlusion.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12306650
• Report Number: 2243441-2021-00035
• Device Sequence Number: 4066923
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/11/2021
• Report Date (Section F): 08/11/2021

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2021
• 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: GOLD WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 82
• Date Report Sent to FDA: 08/11/2021