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

Model Number	H74939216730010
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device separated and detached inside of the patient.A v-14 short taper 300cm straight tip control wire was selected for an angioplasty procedure in the anterior tibial vessel to treat critical limb ischemia (cli).During the procedure, the wire detached inside the heavily calcified vessel.The device fragment was too difficult to retrieve so was secured at the distal end of the anterior tibial vessel.The procedure was cancelled/rescheduled.
Event or Problem Description
It was reported the device separated and detached inside of the patient.A v-14 short taper 300cm straight tip control wire was selected for an angioplasty procedure in the anterior tibial vessel to treat critical limb ischemia (cli).During the procedure, the wire detached inside the heavily calcified vessel.The device fragment was too difficult to retrieve so was secured at the distal end of the anterior tibial vessel.The procedure was cancelled/rescheduled.Additional information was provided from the account that the patient underwent an amputation.
Event or Problem Description
It was reported the device separated and detached inside of the patient.A v-14 short taper 300cm straight tip control wire was selected for an angioplasty procedure in the anterior tibial vessel to treat critical limb ischemia (cli).During the procedure, the wire detached inside the heavily calcified vessel.The device fragment was too difficult to retrieve so was secured at the distal end of the anterior tibial vessel.The procedure was cancelled/rescheduled.It was further reported that the patient underwent an amputation due to disease pathology and part of the treatment plan and was not a patient complication as a result of this event.Also, the procedure was completed and was not cancelled/rescheduled due to 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: 22125887
• Report Number: 2124215-2025-35181
• Device Sequence Number: 7274047
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)261123(10)35351765
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 07/24/2025

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: 0035351765
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 06/26/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/17/2025; 07/24/2025
• Date Device Manufactured: 11/23/2024
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Unknown