MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device fracture occurred.A 200cm, 8cm v-18 guidewire was selected for angioplasty.However, based on the photo provided by the account, the hydrophilic coating of the guidewire was fractured.The procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned.However, a photo was provided from the healthcare facility.It shows that the coating was peeled and the distal tip was kinked.
Event or Problem Description
It was reported that device fracture occurred.A 200cm, 8cm v-18 guidewire was selected for angioplasty.However, based on the photo provided by the account, the hydrophilic coating of the guidewire was fractured.The procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the v-18 guidewire device was returned to our post market quality assurance laboratory.Media, visual and microscopic inspection identified that the coating was peeled, and the distal tip was kinked.Also, the guidewire was kinked as well.This concludes the product analysis.
Event or Problem Description
It was reported that device fracture occurred.A 200cm, 8cm v-18 guidewire was selected for angioplasty.However, based on the photo provided by the account, the hydrophilic coating of the guidewire was fractured.The procedure was completed with this device.There were no patient complications as a result of this event.

• Brand Name: V-18 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: 23380371
• Report Number: 2124215-2025-74353
• Device Sequence Number: 8864110
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: (01)08714729070191(17)270217(10)35875555
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2026

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: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0035875555
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 12/18/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/20/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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