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

Model Number	2480
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that guidewire fracture occurred.The patient presented with coronary artery disease and was undergoing percutaneous coronary intervention.A 182cm j pt graphix guidewire was selected for use.However, while crossing the lesion, a piece of the guidewire broke off in the vessel.The device was removed, and the procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.A2 age at time of event updated a3a sex updated a3b gender updated aa5 ethnicity updated a6 race updated b5 describe event or problem updated e4 init rptr also sent rep to fda updated.G2 report source updated.H6 device code updated.H10 related report number updated.
Event or Problem Description
It was reported that guidewire fracture occurred.The patient presented with coronary artery disease and was undergoing percutaneous coronary intervention.A 182cm j pt graphix guidewire was selected for use.However, while crossing the lesion, a piece of the guidewire broke off in the vessel.The device was removed, and the procedure was completed using an alternate device.No patient complications were reported.It was further reported that it was the tip of the guidewire that broke off during the procedure.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21606924
• Report Number: 2124215-2025-15773
• Device Sequence Number: 18460488
• Product Code: DQX
• UDI-Device Identifier: 08714729141754
• UDI-Public: 08714729141754
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Expiration Date: 05/16/2026
• Device Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0034045456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White