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

Model Number	H74939216730020
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coating of the guidewire tip detached, requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery.After placing a rubicon 14 catheter, a v-14 guidewire was advanced.However, while crossing the lesion, when the guidewire was being advanced and retracted, the hydrophilic coating of the guidewire tip detached and remained in the patient.The detached coating was captured and removed with a snare.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was not returned for analysis since it was discarded at the facility; however, media was provided which showed that the guidewire was kinked at the distal tip and the polymer jacket was peeled which confirms the reported body coating issue.
Event or Problem Description
It was reported that the coating of the guidewire tip detached, requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery.After placing a rubicon 14 catheter, a v-14 guidewire was advanced.However, while crossing the lesion, when the guidewire was being advanced and retracted, the hydrophilic coating of the guidewire tip detached and remained in the patient.The detached coating was captured and removed with a snare.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: 22031522
• Report Number: 2124215-2025-28557
• Device Sequence Number: 12889104
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: (01)08714729799238(17)260906(10)34800660
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/23/2025

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 Expiration Date: 09/06/2026
• Device Model Number: H74939216730020
• Device Catalogue Number: H74939216730020
• Device Lot Number: 0034800660
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 09/06/2024
• 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: Required Intervention
• Patient Sex: Male