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

Model Number	H74939216730010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached.A v-14? control wire? short taper straight tip 300cm guidewire was selected for use in a right leg angioplasty procedure.During the procedure, the proximal half of the guidewire tip broke off inside the patient.The guidewire fragment could not be retrieved.There were no further complications reported.
Additional Manufacturer Narrative
Device history records (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.Risk review: a risk review performed for the v-14 control wire device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was 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(763)494-1632
• MDR Report Key: 50140991
• Report Number: 2124215-2026-41876
• Device Sequence Number: 13444443
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)280127(10)38335791
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/05/2026

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 Model Number: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0038335791
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 01/27/2026
• 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 Sex: Unknown