MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14? CONTROL WIRE?; WIRE, GUIDE, CATHETER

Model Number	H74939216930010
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device lost the distal tip coating.Vascular access was gained via ipsilateral approach.The target lesion was located in the nearly occluded left peroneal artery.A 300cm v-14 control wire guidewire was selected for use in a an angioplasty procedure.An attempt to cross the lesion was made; however, the guidewire failed to cross the lesion.The guidewire was removed from the patient.A fluoroscopy image showed a piece of the wire coating was still in the patients vessel, adjacent to the occlusion.It was not possible to retrieve the piece of the wire coating.The physician was happy to conclude the case at this point as the piece of wire debris could not move past the occluded portion of the vessel.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort attempts were made to retrieve additional details regarding the device status, but further information was unable to be obtained.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual inspection revealed that the distal tip, of the guidewire, was detached.Microscopic inspection revealed the coating hydrophilic was peeled.
Event or Problem Description
It was reported that the device lost the distal tip coating.Vascular access was gained via ipsilateral approach.The target lesion was located in the nearly occluded left peroneal artery.A 300cm v-14 control wire guidewire was selected for use in a an angioplasty procedure.An attempt to cross the lesion was made; however the guidewire failed to cross the lesion.The guidewire was removed from the patient.A fluoroscopy image showed a piece of the wire coating was still in the patients vessel, adjacent to the occlusion.It was not possible to retrieve the piece of the wire coating.The physician was happy to conclude the case at this point as the piece of wire debris could not move past the occluded portion of the vessel.There were no patient complications as a result of this event.It was further reported that there was no attempt to remove the piece of wire coating from the patient and there are no plans to try and retrieve it.

• Brand Name: V-14? 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: 22922569
• Report Number: 2124215-2025-56093
• Device Sequence Number: 9156612
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: (01)08714729799269(17)250921(10)32482033
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112745
• 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
• Report Date (Section B): 10/17/2025

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 Expiration Date: 09/21/2025
• Device Model Number: H74939216930010
• Device Catalogue Number: H74939216930010
• Device Lot Number: 0032482033
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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 Sex: Male