MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14? CONTROL WIRE?; WIRE, GUIDE, CATHETER

Model Number	H74939216730010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The 100% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery (sfa).A 300cm straight tip v-14 control wire was selected for use in a lower extremity angiogram.While crossing a stent in the thrombosed sfa, the tip of the v-14 control wire became stuck in the struts of the stent.When attempting to remove the wire, approximately 2cm of the tip of the wire fractured and the fragment appeared to be lodged in the stent between the arterial wall and the stent.No fragment retrieval was attempted for the remainder of the case as the physician did not see any inherent danger of the wire particle embolizing distally and there was no plan to remove the detached fragment in the near future.An angioplasty of the area where the tip fragment was lodged was performed as part of the standard protocol to treat the lesion.The procedure was completed with the use of other devices.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6 - evaluation conclusion codes: updated.
Event or Problem Description
It was reported that tip detachment occurred.The 100% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery (sfa).A 300cm straight tip v-14 control wire was selected for use in a lower extremity angiogram.While crossing a stent in the thrombosed sfa, the tip of the v-14 control wire became stuck in the struts of the stent.When attempting to remove the wire, approximately 2cm of the tip of the wire fractured and the fragment appeared to be lodged in the stent between the arterial wall and the stent.No fragment retrieval was attempted for the remainder of the case as the physician did not see any inherent danger of the wire particle embolizing distally and there was no plan to remove the detached fragment in the near future.An angioplasty of the area where the tip fragment was lodged was performed as part of the standard protocol to treat the lesion.The procedure was completed with the use of other devices.There were no patient complications as a result of this event.

• Brand Name: V-14? CONTROL WIRE?
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23056562
• Report Number: 2124215-2025-62775
• Device Sequence Number: 9383254
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)260807(10)34590793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 08/07/2026
• Device Model Number: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0034590793
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/10/2025
• Date Device Manufactured: 08/07/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Race: Black Or African American