MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HORNET 14; CATHETER, GUIDEWIRE

Model Number	2831
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
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 tip detachment occurred.During an attempt to advance a 190cm straight tip, hornet 14 guidewire through a chronic total occlusion in the coronary artery, the distal tip of the wire fractured and remained within the vessel.The fragment was subsequently embedded by the deployed stent.The procedure was completed successfully.There were no patient complications.
Event or Problem Description
It was reported that tip detachment occurred.During an attempt to advance a 190cm straight tip, hornet 14 guidewire through a chronic total occlusion in the coronary artery, the distal tip of the wire fractured and remained within the vessel.The fragment was subsequently embedded by the deployed stent.The procedure was completed successfully.There were no patient complications.
Additional Manufacturer Narrative
H6 impact codes: corrected good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: HORNET 14
• Common Device Name: CATHETER, GUIDEWIRE
• 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: 23137462
• Report Number: 2124215-2025-64949
• Device Sequence Number: 15774185
• Product Code: DQX
• UDI-Device Identifier: 08714729887751
• UDI-Public: (01)08714729887751(17)261203(10)32985207
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 2831
• Device Catalogue Number: 2831
• Device Lot Number: 0032985207
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 12/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown