MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 Control Wire; wire, guide, catheter

Model Number	40535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture requiring additional intervention.The target lesion was located in a lower extremity artery.A 300cm, 12cm v-18 guidewire was advanced for lesion crossing; however, during crossing, the tip of the guidewire fractured and detached inside the patients vessel.The physician successfully snared and removed the detached fragment, and another v-18 guidewire was used to complete the procedure.No patient complications and the patient was stable 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50566529
• Report Number: 2124215-2026-46485
• Device Sequence Number: 10104886
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: (01)08714729070238(17)280303(10)38748876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0038748876
• 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: 08/05/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 03/04/2026
• 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: Required Intervention
• Patient Sex: Unknown