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

Model Number	H74939216930010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the wire broke off within the artery, requiring additional intervention.During a lower extremity (le) angiogram, the target lesion was located in the severely tortuous and severely calcified posterior tibial (pt) artery.A long taper 300 cm straight tip v-14 control wire guidewire was selected for use.While crossing the lesion, the tip of the guidewire fractured and broke off within the pt artery.The physician attempted to retrieve the separated tip using a snare device; however, retrieval efforts were unsuccessful due to the severity of the vessel calcification.The fractured tip remained within the artery, and the procedure was completed.No additional information was provided.
Event or Problem Description
It was reported that the tip of the wire broke off within the artery, requiring additional intervention.During a lower extremity (le) angiogram, the target lesion was located in the severely tortuous and severely calcified posterior tibial (pt) artery.A long taper 300 cm straight tip v-14 control wire guidewire was selected for use.While crossing the lesion, the tip of the guidewire fractured and broke off within the pt artery.The physician attempted to retrieve the separated tip using a snare device; however, retrieval efforts were unsuccessful due to the severity of the vessel calcification.The fractured tip remained within the artery, and the procedure was completed.No additional information was provided.It was further reported that the patient condition was good following procedure.

• 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: 23604614
• Report Number: 2124215-2025-79881
• Device Sequence Number: 13223697
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: (01)08714729799269(17)270506(10)36454175
• 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,Followup
• Report Date (Section B): 12/11/2025

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 Model Number: H74939216930010
• Device Catalogue Number: H74939216930010
• Device Lot Number: 0036454175
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 05/06/2025
• 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