MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14? Control Wire?; wire, guide, catheter

Model Number	H74939216730010
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the wire became stuck and began to separate.A v-14? control wire? was selected for use in the plain old balloon angioplasty (poba) procedure.The target lesion was located in the 90% stenosed anterior tibial artery, and was both moderately calcified and tortuous.During the procedure, while crossing the lesion, the wire became stuck within the patient anatomy.The wire was removed from the patient in one piece.Upon removal, it was observed that the tip of the wire had begun to peel.The wire was replaced, and the procedure was completed without further issue.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the wire became stuck and began to separate.A v-14? control wire? was selected for use in the plain old balloon angioplasty (poba) procedure.The target lesion was located in the 90% stenosed anterior tibial artery, and was both moderately calcified and tortuous.During the procedure, while crossing the lesion, the wire became stuck within the patient anatomy.The wire was removed from the patient in one piece.Upon removal, it was observed that the tip of the wire had begun to peel.The wire was replaced, and the procedure was completed without further issue.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Investigation results: media review: media in the form of images was provided by the customer.The images showed the polymer sleeve was peeled and detached, confirming the reported fracture.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the v-14? control wire? device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24778920
• Report Number: 2124215-2026-18362
• Device Sequence Number: 6133303
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)271113(10)37954363
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2026

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: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0037954363
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 06/26/2026; 08/14/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/11/2026; 07/21/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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