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

Model Number	40495
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis since it was discarded at facility, however, media attached to the parent record shows the detached in the tip in the x-ray procedure, which confirms the reported distal tip detachment of device or device component.Since there is evidence that the guidewire was detached, it is also possible to confirm the reported spring tip difficult to remove/withdraw from lesion.
Event or Problem Description
It was reported that tip detachment occurred, and fragment remains inside the patient's body.The 100% stenosed target lesion was located in the severely calcified subclavian artery occlusion.A 300cm, 8cm v-18 control wire was selected for use.During the procedure, it was noted that the guidewire became stuck in the lesion plaque.During retrieval, excessive force may have been applied to the device causing the tip to fracture.The broken tip remains in the patient's body.An attempt to remove the fragments was unsuccessful.The patient has plans to go to another hospital to retrieve the guidewire, but the specific time is unknown.Due to v18 fracturing during the treatment of complete occlusion of the subclavian artery, the physician transferred to treat the occlusion of the right vertebral artery.The subclavian artery remains 100% occluded.The procedure was successfully completed, and the patient was discharged.There were no patient complications as a result of this event.The patient was stable post procedure.
Event or Problem Description
It was reported that tip detachment occurred, and fragment remains inside the patient's body.The 100% stenosed target lesion was located in the severely calcified subclavian artery occlusion.A 300 cm, 8 cm v-18 control wire was selected for use.During the procedure, it was noted that the guidewire became stuck in the lesion plaque.During retrieval, excessive force may have been applied to the device causing the tip to fracture.The broken tip remains in the patient's body.An attempt to remove the fragments was unsuccessful.The patient has plans to go to another hospital to retrieve the guidewire, but the specific time is unknown.Due to v18 fracturing during the treatment of complete occlusion of the subclavian artery, the physician transferred to treat the occlusion of the right vertebral artery.The subclavian artery remains 100% occluded.The procedure was successfully completed, and the patient was discharged.There were no patient complications as a result of this event.The patient was stable post procedure.

• 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: 21936275
• Report Number: 2124215-2025-21911
• Device Sequence Number: 20806496
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)260918(10)34881081
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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 Expiration Date: 09/18/2026
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0034881081
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 09/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male