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

Model Number	40495
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the hydrophilic coating was fractured, migrated and remained inside patient.The patient underwent interventional treatment for right lower limb arteriosclerotic occlusion.A 300cm, 8cm v-18 control wire was selected for use.During the procedure, the coating at the tip of the wire with hydrophilic coating was fractured and fell into the anterior tibial artery.After the procedure, the blood supplied to the lower limbs of the patient improved compared to before, and there were no pain or other discomforts.On (b)(6) 2025, the imaging examination confirmed that the fallen coating had travelled through the bloodstream to the extremities and could not be removed.The patient did not experience any discomfort.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the tip of the hydrophilic coating was fractured, migrated and remained inside patient.The patient underwent interventional treatment for right lower limb arteriosclerotic occlusion.A 300cm, 8cm v-18 control wire was selected for use.During the procedure, the coating at the tip of the wire with hydrophilic coating was fractured and fell into the anterior tibial artery.After the procedure, the blood supplied to the lower limbs of the patient improved compared to before, and there were no pain or other discomforts.On (b)(6) 2025, the imaging examination confirmed that the fallen coating had travelled through the bloodstream to the extremities and could not be removed.The patient did not experience any discomfort.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 100% stenosed, moderately tortuous, and severely calcified.There are no plans to attempt removal of the device fragments remaining inside the patient's body.There was no patient injury resulting from this event, and the patient was normal and stable post-procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that the tip of the hydrophilic coating was fractured, migrated and remained inside patient.The patient underwent interventional treatment for right lower limb arteriosclerotic occlusion.A 300cm, 8cm v-18 control wire was selected for use.During the procedure, the coating at the tip of the wire with hydrophilic coating was fractured and fell into the anterior tibial artery.After the procedure, the blood supplied to the lower limbs of the patient improved compared to before, and there were no pain or other discomforts.On 10-sep-2025, the imaging examination confirmed that the fallen coating had travelled through the bloodstream to the extremities and could not be removed.The patient did not experience any discomfort.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 100% stenosed, moderately tortuous, and severely calcified.There are no plans to attempt removal of the device fragments remaining inside the patient's body.There was no patient injury resulting from this event, and the patient was normal and stable post-procedure.
Additional Manufacturer Narrative
H6: evaluation conclusion codes: updated.

• 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: 23246325
• Report Number: 2124215-2025-70207
• Device Sequence Number: 13368402
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)260824(10)34707595
• 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: 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: 08/24/2026
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0034707595
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 10/27/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/27/2025; 11/24/2025
• Date Device Manufactured: 08/24/2024
• 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: 60 YR
• Patient Sex: Male