MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE; 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	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the involve glidewire wire broke off in the patient during a procedure.They were able to retrieve the tip of the wire with a snare, and nothing was left inside the patient.There was no harm to the patient.The reported event did not result in patient injury or require surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury.The event occurred intra-operative.Additional information was received on 07 mar 2024: the procedure performed was a thrombectomy with inari equipment.The patient's anatomy was tortuous when working with the wire that broke.The size of wire tip that broke off was 3 centimeters (cm).They were using an inari's thrombectomy device with the guidewire at the time of breakage.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18987234
• Report Number: 2243441-2024-00006
• Device Sequence Number: 8265530
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2024
• Report Date (Section F): 03/27/2024

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: GA3502
• Device Lot Number: 230914
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/04/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• 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: INARI'S THROMBECTOMY DEVICE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/27/2024