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	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device detachment occurred requiring intervention.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 300cm, 8cm poly tip v-18 control wire was selected for use.During the procedure, it was noted that the tip part of the device was separated.There was resistance in removing the device and the device part was caught with a snare.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that device detachment occurred requiring intervention.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 300cm, 8cm poly tip v-18 control wire was selected for use.During the procedure, it was noted that the tip part of the device was separated.There was resistance in removing the device and the device part was caught with a snare.There were no patient complications as a result of this event.It was further reported that no remnants of the detached tip remained inside the patient's body, as the detached portion was successfully retrieved using a snare device.During the procedure, the v-18 guidewire was used specifically in the anterior tibial artery.
Additional Manufacturer Narrative
A2: age at time of event: the patient is in their 70's.

• 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: 23850310
• Report Number: 2124215-2025-92008
• Device Sequence Number: 9817510
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)270701(10)36873605
• 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): 01/21/2026

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: 0036873605
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 07/01/2025
• 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