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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed patient outcome information was not provided to bsc.We completed a good faith effort to obtain the information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that tip detachment occurred.A 300cm straight tip v-14 control wire was selected for use in a peripheral intervention procedure.The target lesion was a chronic total occlusion in the left popliteal artery.Vascular access was performed via contralateral approach, and an attempt was made to cross the occlusion with the wire and a non-boston scientific shockwave device.It was noted that the tip of the wire was outside the shockwave device.The lesion was treated with 120 pulses, and when pulling the device and wire back, it was observed that the tip of the wire had sheared off.It was noted the device was partially explanted, a portion remained implanted, and the procedure was not completed.
Additional Manufacturer Narrative
Detailed patient outcome information was not provided to bsc.We completed a good faith effort to obtain the information.If additional details become available, a supplemental report will be submitted.The device was not returned but device analysis was performed using the photo received.X-ray confirmed that the device was kinked at the distal tip and the polymer jacket was detached and peeled.
Event or Problem Description
It was reported that tip detachment occurred.A 300cm straight tip v-14 control wire was selected for use in a peripheral intervention procedure.The target lesion was a chronic total occlusion in the left popliteal artery.Vascular access was performed via contralateral approach, and an attempt was made to cross the occlusion with the wire and a non-boston scientific shockwave device.It was noted that the tip of the wire was outside the shockwave device.The lesion was treated with 120 pulses, and when pulling the device and wire back, it was observed that the tip of the wire had sheared off.It was noted the device was partially explanted, a portion remained implanted, and the procedure was not completed.

• 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: 21946297
• Report Number: 2124215-2025-24917
• Device Sequence Number: 18276456
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)270212(10)35845180
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/26/2025

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: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0035845180
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/26/2025
• Date Device Manufactured: 02/12/2025
• 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
• Patient Age: 79 YR
• Patient Sex: Male