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

Model Number	H74939216730010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the left distal anterior tibial artery.A 300cm v-14 control wire was selected for use.During the procedure, it was noted that the distal tip of the wire detached and about 1cm length was left behind in the patient's left tibial artery.The wire tip was attempted to snare however, it was unsuccessful.The procedure was completed using an alternate device.

• 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: 22778244
• Report Number: 2124215-2025-55632
• Device Sequence Number: 9119984
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)260412(10)33816473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/11/2025

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: 04/12/2026
• Device Model Number: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0033816473
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 04/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown