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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire gold tip detached from the wire when doing a peripheral artery disease (pad) case.The wire was deployed through an 018 navicross.Glidesheath slender tp was the sheath used in the case from a pedal approach.The patient was in stable condition.The procedure was successful, and no medical or surgical intervention was required.Additional information was received on (b)(6) 2023: the doctor stated they thought the tip might have been left/stuck in the sheath and not in the patient.Under x-ray, they cannot see the tip.The wire was retrieved from the patient.

• 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: 16818665
• Report Number: 2243441-2023-00018
• Device Sequence Number: 12536547
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: 04987350711908
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2023
• Report Date (Section F): 04/26/2023

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 Model Number: N/A
• Device Catalogue Number: GM1831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2023
• 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: 018 NAVICROSS.; GLIDESHEATH SLENDER TP.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 04/26/2023