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

Model Number	40495
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the superficial femoral artery (sfa).A 300cm, 8cm v-18 control wire guidewire was selected to treat peripheral artery disease (pad) in an endovascular therapy (evt).During the procedure, the tip of the guidewire became lodged in a branch.To extract it, the guidewire was pulled, resulting in its removal from the microcatheter.At that point, it was discovered that the tip of the guidewire remained in the sfa, confirming a fracture.A gooseneck snare was used to retrieve the fragment.The procedure was completed with another of the same device and a stent was placed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the v-18 control wire device was returned to our post market quality assurance laboratory.The distal tip returned fully detached.The device was inspected under magnification, and it was possible to see that the distal tip returned fully detached.Also, it is stretched and peeled.This concludes the product analysis.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the superficial femoral artery (sfa).A 300cm, 8cm v-18 control wire guidewire was selected to treat peripheral artery disease (pad) in an endovascular therapy (evt).During the procedure, the tip of the guidewire became lodged in a branch.To extract it, the guidewire was pulled, resulting in its removal from the microcatheter.At that point, it was discovered that the tip of the guidewire remained in the sfa, confirming a fracture.A gooseneck snare was used to retrieve the fragment.The procedure was completed with another of the same device and a stent was placed.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: 24004882
• Report Number: 2124215-2026-01258
• Device Sequence Number: 21183793
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)270624(10)36832139
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0036832139
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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 Sex: Unknown