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	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) medical university.E1: phone number: (b)(6) reported here as phone number exceeded character limit for designated field.Good faith effort attempts were made to try and retrieve additional details regarding the initial reporter details, but further information was unable to be obtained.
Event or Problem Description
The strength of the soft tip of the guide wire was insufficient.On (b)(6) 2025, a patient was treated for left iliac vein compression syndrome using a 300cm, 8cm poly tip v-18 control wire with a hydrophilic coating and a single-curved angiography catheter.During the procedure, it was noted that the guide wire was fractured.The device was removed, and the procedure was completed.There were no patient complications as a result of this event.
Event or Problem Description
The strength of the soft tip of the guide wire was insufficient.On (b)(6) 2025, a patient was treated for left iliac vein compression syndrome using a 300cm, 8cm poly tip v-18 control wire with a hydrophilic coating and a single-curved angiography catheter.During the procedure, it was noted that the guide wire was fractured.The device was removed, and the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter: updated the physician details e1: (b)6).
Event or Problem Description
The strength of the soft tip of the guide wire was insufficient.On (b)(6) 2025, a patient was treated for left iliac vein compression syndrome using a 300cm, 8cm poly tip v-18 control wire with a hydrophilic coating and a single-curved angiography catheter.During the procedure, it was noted that the guide wire was fractured.The device was removed, and the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter: updated the physician details.E1: initial reporter facility name: (b)(6).The device was not returned.However, a photo was provided from the healthcare facility.It shows that the distal tip was detached.

• 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: 22890155
• Report Number: 2124215-2025-59019
• Device Sequence Number: 4864584
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)260912(10)34834588
• 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,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 09/12/2026
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0034834588
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 10/31/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/24/2025
• Date Device Manufactured: 09/12/2024
• 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: 57 YR
• Patient Sex: Female