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

Model Number	40495
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an issue involving the guidewire coating occurred.A 300cm, 8cm v-18 control wire was selected for use in a balloon dilatation procedure of the left lower limb.A supporting catheter was utilized to access and open the vessel over the 0.018 guidewire.After the guidewire entered the patient, the coating was observed to have fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.(b)(6).
Event or Problem Description
It was reported that an issue involving the guidewire coating occurred.A 300cm, 8cm v-18 control wire was selected for use in a balloon dilatation procedure of the left lower limb.A supporting catheter was utilized to access and open the vessel over the 0.018 guidewire.After the guidewire entered the patient, the coating was observed to have fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.It was further reported that the soft tip at the front end of the guidewire peeled off during the procedure, and the coating on the posterior part of the guidewire was found to be detached.This damage occurred during use.The lesion itself was not particularly challenging, and the patients anatomy did not contribute to the issue.The guidewire was inserted through an 18-french support catheter but became stuck at the distal end.When the physician attempted to retract the guidewire, the coating at the distal end fractured.The event was not attributed to any patient factors, and procedural factors were not believed to have contributed to the reported issue.

• 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: 23760193
• Report Number: 2124215-2025-85328
• Device Sequence Number: 18625322
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)270311(10)36047064
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0036047064
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 03/11/2025
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 53 KG