MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT GRAPHIX¿; WIRE, GUIDE, CATHETER

Model Number	H74914914011
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the approximal mid thigh, a large area of total occlusion was noted.The wire got stuck.A small portion of the tip of the wire snapped off.The md shot further pictures which confirmed chronic total occlusion.The wire remained in the patient's right thigh.

• Brand Name: PT GRAPHIX¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23061900
• Report Number: 23061900
• Device Sequence Number: 13177308
• Product Code: DQX
• UDI-Device Identifier: 08714729255017
• UDI-Public: (01)08714729255017(17)260312(10)33617224
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2025
• Report Date (Section F): 09/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74914914011
• Device Lot Number: 33617224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 51 KG
• Date Report Sent to FDA: 09/08/2025