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

Model Number	H74939216730010
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire coating was peeled off.The over 70% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 300cm straight tip v-14 control wire was selected for percutaneous transluminal angioplasty.However, during the procedure, it was noted that the guidewire coating was peeled off.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the v-14 control wire device was returned to our post market quality assurance laboratory.Visual inspection was performed and identified that it was bent at distal tip.Microscopic inspection was performed and revealed that the coating hydrophilic was peeled.This concludes the product analysis.
Event or Problem Description
It was reported that the guidewire coating was peeled off.The over 70% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 300cm straight tip v-14 control wire was selected for percutaneous transluminal angioplasty.However, during the procedure, it was noted that the guidewire coating was peeled off.The procedure was completed with another of the same device.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: 23026372
• Report Number: 2124215-2025-62944
• Device Sequence Number: 13182065
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)270506(10)36454465
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 0036454465
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown