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

Model Number	GR3506
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire broke off inside of the patient.The patient was not harmed.Additional information was received on 30apr2025: patient underwent a diagnostic atrioventricular (av) fistula with attempted recanalization of thrombosed cephalic arch stent.They were able to retrieve and subsequently exteriorize foreign body with a snare and catheter.The guidewire that broke off was a 0.035 wire.The wire was used with a 5fr kumpe catheter.The patient was stable and there was no hemodynamic issues encountered.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, 418-0 015; JA 418-0015
• MDR Report Key: 22079549
• Report Number: 2243441-2025-00021
• Device Sequence Number: 18318364
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: (01)04987350773159(17)260630(10)240704
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/23/2025
• Report Date (Section F): 05/23/2025

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 Expiration Date: 06/30/2026
• Device Model Number: GR3506
• Device Catalogue Number: RF*GA35153A
• Device Lot Number: 240704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/29/2025
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/23/2025