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

Model Number	40495
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that advancement difficulty occurred.The stenosed target lesion was located in the below the knee vessel, a 300cm, 8cm v-18 control wire was selected for use.During the procedure, the product was inserted into the catheter, however, the coil was interrupted.The procedure was canceled.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned for evaluation in a generic plastic bag.Overall visual inspection revealed no damage or evidence that could have been introduced or obscured by the decontamination process.One v-18 control wire was received for analysis.The distal tip and the remainder of the guidewire were found to be in good condition.No coating delamination, kinks, or bends were observed.Overall, no abnormalities were identified with the returned device.
Event or Problem Description
It was reported that advancement difficulty occurred.The stenosed target lesion was located in the below the knee vessel, a 300cm, 8cm v-18 control wire was selected for use.During the procedure, the product was inserted into the catheter, however, the coil was interrupted.The procedure was canceled.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: 23511551
• Report Number: 2124215-2025-80433
• Device Sequence Number: 9955022
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)270604(10)36682373
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/17/2025

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: 0036682373
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: 78 YR
• Patient Sex: Female