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

Model Number	GM1831
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire gold tip sheared off the wire during the procedure.The tip of the wire went off in a branch of the profunda, so it caused no harm to patient, however, they were not able to retrieve the wire tip.The small branch was feeding nowhere so it caused no harm.The patient was stable, and the procedure was a success.Additional information was received on (b)(6) 2021.The procedure was a peripheral artery disease (pad) case.

• 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: 12813518
• Report Number: 2243441-2021-00060
• Device Sequence Number: 20227757
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: 04987350711908
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/15/2021
• Report Date (Section F): 11/15/2021

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: 12/31/2022
• Device Model Number: GM1831
• Device Catalogue Number: GM1831
• Device Lot Number: 210126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 11/15/2021