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

Model Number	H74939216718210
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a device component detached and became stuck inside of the patient.A v-14? control wire? was selected for a procedure.During this event, a device component detached and became stuck inside of the patient.No patient complications occurred.
Additional Manufacturer Narrative
H11: device evaluation by manufacturer: unit returned with its original box batch 35400110 overall visual inspection did not identify failures or evidence that could be lost due to decontamination process.The device was inspected according to procedure.The guidewire was returned, and it was observed that the distal tip was bent and detached, moreover the polymer jacket was peeled.The guidewire was bent, detached and peeled.
Event or Problem Description
It was reported a device component detached and became stuck inside of the patient.A v-14? control wire? was selected for a procedure.During this event, a device component detached and became stuck inside of the patient.There were no patient complications as a result of this event.

• 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: 21933885
• Report Number: 2124215-2025-26816
• Device Sequence Number: 8907373
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: (01)08714729799207(17)261202(10)35400110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/10/2025

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: H74939216718210
• Device Catalogue Number: H74939216718210
• Device Lot Number: 0035400110
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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 Sex: Unknown