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

Model Number	40495
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	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medwatch (b)(4) device fracture occurred requiring intervention.The target lesion was located in the vessel in the lung.A 200cm, 8cm v-18 control wire was selected for use.During the procedure, a wire component from the intravascular equipment was fractured and migrated from the vein to the pulmonary region to the lung.Imaging confirms it location and was successfully retrieved.This extended the procedure and resulted in additional fluoroscopic exposure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3 - date of event: event date not provided.
Event or Problem Description
It was reported that medwatch (b)(4) device fracture occurred requiring intervention.The target lesion was located in the vessel in the lung.A 200cm, 8cm v-18 control wire was selected for use.During the procedure, a wire component from the intravascular equipment was fractured and migrated from the vein to the pulmonary region to the lung.Imaging confirms it location and was successfully retrieved.This extended the procedure and resulted in additional fluoroscopic exposure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3 - date of event: event date not provided.H10 - related report number: (b)(4).

• 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: 23693562
• Report Number: 2124215-2025-86941
• Device Sequence Number: 15751340
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: (01)08714729070191(17)270324(10)36141758
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0036141758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 03/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male