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

Model Number	H74939216718210
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent delivery system became stuck on the guidewire.A v-14 control wire was selected for use.A carotid wallstent was advanced over the v-14 without issue.After the wallstent was successfully deployed, the physician went to withdraw the stent delivery system.There was difficulty withdrawing, and the delivery system became stuck on the v-14.The guidewire and delivery system were removed as one unit.Outside of the patient, the guidewire and delivery system were able to be separated.There were no patient complications.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes, evaluation conclusion codes.
Event or Problem Description
It was reported that the stent delivery system became stuck on the guidewire.A v-14 control wire was selected for use.A carotid wallstent was advanced over the v-14 without issue.After the wallstent was successfully deployed, the physician went to withdraw the stent delivery system.There was difficulty withdrawing, and the delivery system became stuck on the v-14.The guidewire and delivery system were removed as one unit.Outside of the patient, the guidewire and delivery system were able to be separated.There were no patient complications.

• 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: 22365871
• Report Number: 2124215-2025-42566
• Device Sequence Number: 12834394
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: (01)08714729799207(17)261202(10)35400110
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 07/30/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAROTID WALLSTENT; CAROTID WALLSTENT
• Patient Age: 70 YR
• Patient Sex: Unknown