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

Model Number	H74939216930010
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, patient information, initial reporter, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the hydrophilic coating was missing from the guidewire.A v-14 control wire was selected for use in balloon angioplasty procedure in the tibial artery.It was inserted through a micropuncture kit and non-bsc support catheter into the pedal artery.When the v-14 control wire was removed, it was observed that the hydrophilic coating was missing from the guidewire.Subsequent fluoroscopic pictures were taken, and in which no part of the guidewire was found (in-situ).The surgeon was not concerned, and no further procedures will be undertaken due to this event.There were no patient complications as a result of the event.
Event or Problem Description
It was reported that the hydrophilic coating was missing from the guidewire.A v-14 control wire was selected for use in balloon angioplasty procedure in the tibial artery.It was inserted through a micropuncture kit and non-bsc support catheter into the pedal artery.When the v-14 control wire was removed, it was observed that the hydrophilic coating was missing from the guidewire.Subsequent fluoroscopic pictures were taken, and in which no part of the guidewire was found (in-situ).The surgeon was not concerned, and no further procedures will be undertaken due to this event.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned.However, a photo was provided from the healthcare facility.It shows that the coating of the guidewire was peeled and bent.

• 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: 23203189
• Report Number: 2124215-2025-69779
• Device Sequence Number: 10061604
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: (01)08714729799269(17)270320(10)36114450
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: H74939216930010
• Device Catalogue Number: H74939216930010
• Device Lot Number: 0036114450
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 03/20/2025
• 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 Sex: Unknown