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

Model Number	GM1811
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the wire or marker band broke off in the lesion in the peroneal artery during a peripheral vascular disease (pvd) intervention.The patient was in good condition; however, they were not able to complete the intervention due to extensive disease.Additional information was received on 22oct2021.The broken tip or marker band remains in the patient.The marker band/tip is in the peroneal artery, lodged where it is occluded with calcium.Fluoro was done to confirm the location.

• 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: 12808692
• Report Number: 2243441-2021-00058
• Device Sequence Number: 5575604
• Product Code: DQX
• UDI-Device Identifier: 04987350774194
• UDI-Public: 04987350774194
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/14/2021
• Report Date (Section F): 11/14/2021

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: GM1811
• Device Catalogue Number: GM1811
• Device Lot Number: 210201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/20/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2021
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White
• Date Report Sent to FDA: 11/14/2021