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

Model Number	GA3502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they had a peripheral case with an up an over technique by accessing contralateral side to take wire up and over the corina into the opposite iliac.The wire broke while across the steep bifurcating common iliac.The wire broke into two pieces.The part where the wire broke was at the metal area proximal to the hydrophilic part of the wire.The distal broken part of the wire remained in the body when pulling the wire back from catheter and part of the wire remained in the catheter.The wire was removed via a cut down of the other side common femoral artery (cfa) and the case was completed through a cut down endodarctomy of the common femoral artery (cfa) and a endovascular repair and revascularization of the superficial femoral artery (sfa) through the cut down of the common femoral artery (cfa).The estimated blood loss was less than 250cc.

• 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: 22696657
• Report Number: 2243441-2025-00040
• Device Sequence Number: 13008456
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: (01)04987350703644(17)261231(10)250106
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/03/2025
• Report Date (Section F): 08/03/2025

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
• Device Lot Number: 250106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2025
• 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: 5FR 100CM GLIDECATH; MULTIPLE CATHETERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/03/2025