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	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire detachment occurred requiring additional intervention.During an endovascular procedure, a fragment of a 300 cm, 12 cm poly tip v-18 control wire broke off in the patient.The surgeons immediately recognized the issue and used a snare to retrieve the detached piece.A fluoroscopic run was performed to confirm complete removal of the fragment.Both wire and broken piece were inspected and confirmed all removed.No further information was reported.
Additional Manufacturer Narrative
Additional event details were not provided to bsc.We completed a good faith effort to obtain the information.If additional details become available, a supplemental report will be submitted.

• 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: 23756400
• Report Number: 2124215-2025-86793
• Device Sequence Number: 21228510
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: (01)08714729070238(17)270710(10)36935763
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0036935763
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 07/10/2025
• 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 Sex: Unknown