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

Model Number	H74939216930020
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with cold leg and underwent angiogram.The target lesions were located in the 99% occluded superficial femoral artery (sfa) and 100% occluded posterior tibial artery (pta).The lesion characteristics were moderately tortuous and moderately calcified.After advancing a 300cm angled tip v-14 control wire, a 2.5mm x 220mm x 150cm coyote balloon catheter was advanced over the wire; however, resistance was noted.Following dilatation, an attempt was made to advance the wire and the balloon further distally when the tip of the wire sheared off.The detached tip was left inside the patient up against the vessel wall.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the v-14 control wire was returned for analysis.Visual and microscope inspections were performed.It was observed that part of the distal tip was detached, but the detach section did not return for analysis.Also, the rest of the distal tip was kinked.No other issues were identified with the device.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with cold leg and underwent angiogram.The target lesions were located in the 99% occluded superficial femoral artery (sfa) and 100% occluded posterior tibial artery (pta).The lesion characteristics were moderately tortuous and moderately calcified.After advancing a 300cm angled tip v-14 control wire, a 2.5mm x 220mm x 150cm coyote balloon catheter was advanced over the wire; however, resistance was noted.Following dilatation, an attempt was made to advance the wire and the balloon further distally when the tip of the wire sheared off.The detached tip was left inside the patient up against the vessel wall.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: 23305717
• Report Number: 2124215-2025-72547
• Device Sequence Number: 17593085
• Product Code: DQX
• UDI-Device Identifier: 08714729799276
• UDI-Public: (01)08714729799276(17)261202(10)35401108
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/12/2025

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 Model Number: H74939216930020
• Device Catalogue Number: H74939216930020
• Device Lot Number: 0035401108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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 Sex: Unknown