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

Model Number	GA3502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user faculty reported that radial to peripheral cases resulted in a significant aortic dissection from the heart to the distal aorta.It is unclear if the glidewire advantage was the cause of the dissection.The equipment used included the glidewire advantage, 400 stiff angle glide, 119cm destination slender, and 200cm navicross.The dissection was not noticed during the procedure, but the patient later required open surgery and experienced shutdown of the opposite leg.Blood loss was less than 250cc.The reported event resulted in patient injury and required medical or surgical intervention.Surgery was necessary to repair the total aortic dissection and the clotted left leg.The event occurred post-operatively.

• Brand Name: GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 21517267
• Report Number: 2243441-2025-00003
• Device Sequence Number: 12875524
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025
• Report Date (Section F): 03/04/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• 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: 119CM DESTINATION SLENDER; 200CM NAVICROSS; 260 GLIDEWIRE ADVANTAGE OMNIFLUSH; 400CM STIFF GLIDEWIRE; 6FR GLIDESHEATH SLENDER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/04/2025