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 Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try retrieve product status and additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that tip detachment and vessel occlusion occurred, and the procedure was cancelled.During the intervention, a v-14 short taper 300 cm straight tip wire was used in an attempt to cross the chronic total occlusion (cto) of the anterior tibial artery.While advancing through a collateral vessel, the wire tip fractured and remained within the vessel, resulting in partial occlusion of the collateral.Thrombosis was also noted.After evaluation, the physician elected to discontinue attempts to cross the anterior tibial cto.The retained wire tip was left in place, as it was assessed to pose no significant clinical risk.The anterior tibial branch remained occluded, consistent with an inflow/outflow issue.Consequently, the procedure was not completed due to this event.
Additional Manufacturer Narrative
Correction to h6 patient codes and h6: impact codes.The device was not returned for analysis; however, the customer provided a picture of the device.The picture showed a v-14 control wire, and it was possible to observe that the distal tip was detached; however, the detached section was not visible.This confirmed the reported event of distal tip detachment of device or device component that is related with tip distal detached/separated.
Event or Problem Description
It was reported that tip detachment and vessel occlusion occurred, and the procedure was cancelled.During the intervention, a v-14 short taper 300 cm straight tip wire was used in an attempt to cross the chronic total occlusion (cto) of the anterior tibial artery.While advancing through a collateral vessel, the wire tip fractured and remained within the vessel, resulting in partial occlusion of the collateral.Thrombosis was also noted.After evaluation, the physician elected to discontinue attempts to cross the anterior tibial cto.The retained wire tip was left in place, as it was assessed to pose no significant clinical risk.The anterior tibial branch remained occluded, consistent with an inflow/outflow issue.Consequently, the procedure was not completed due to this event.It was further reported that the 100% stenosed target lesion was located in the non-tortuous and moderately calcified anterior tibial artery.The patients anatomy was considered challenging, and patient-related factors contributed to the reported event; however, no procedural factors were identified as contributing.The patient remained in stable condition following the 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: 23659949
• Report Number: 2124215-2025-85733
• Device Sequence Number: 10055619
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)261107(10)35237201
• 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): 12/15/2025

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: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0035237201
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 11/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: Black Or African American