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	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire tip broke.The stenosed target lesion was located in the severely tortuous and severely calcified anterior tibial vessel.A 300cm straight tip v-14? control wire? was selected for use.During the procedure while crossing the lesion, the hydrophilic tip detached and remained in a small branch of the anterior tibial vessel.The rest of the device was removed from the body.The physician elected to leave the tip in place, considering the risk minimal and the branch small enough.The procedure was completed with an alternate device.No adverse effects were observed from leaving the tip behind.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual and microscopic inspections were performed, and it was observed that the guidewire was bent and detached at the distal tip.Additionally, the coating was peeled.Analysis of the media provided by the customer also confirmed that the guidewire had peeled.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the guidewire tip broke.The stenosed target lesion was located in the severely tortuous and severely calcified anterior tibial vessel.A 300cm straight tip v-14? control wire? was selected for use.During the procedure while crossing the lesion, the hydrophilic tip detached and remained in a small branch of the anterior tibial vessel.The rest of the device was removed from the body.The physician elected to leave the tip in place, considering the risk minimal and the branch small enough.The procedure was completed with an alternate device.No adverse effects were observed from leaving the tip behind.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: 23145193
• Report Number: 2124215-2025-66256
• Device Sequence Number: 15916812
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)270622(10)36810134
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/03/2025

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: 0036810134
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2025
• 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 Sex: Unknown