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

Model Number	GA3502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the wire tip broke off in patient while trying to balloon.There was no blood loss.Additional information was received on 18oct2024: the procedure was a splenic thrombectomy.The wire tip was removed from the patient.The patient was stable and there was no harm.The procedure was completed successfully.

• Brand Name: 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: 20670811
• Report Number: 2243441-2024-00028
• Device Sequence Number: 7238914
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: (01)04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/12/2024
• Report Date (Section F): 11/12/2024

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 Model Number: GA3502
• Device Catalogue Number: RA*CA35265C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• 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: BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/12/2024