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

Model Number	H74939216730020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire break occurred.The target lesion was located in a non-tortuous right anterior tibial artery.During procedure, v14 wire and non-boston scientific catheter were advanced into the artery, and vessel was inflated by a 3mm balloon.Upon removal, broken piece seen on angiogram.The broken piece was retrieved with the catheter and removed from the patient.The procedure was completed using an alternate method.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the v-14 control wire was returned for analysis.A visual examination identified that the polymer jacket was fracture/peeled, moreover the distal tip was bent.No further issues were confirmed in the analysis.
Event or Problem Description
It was reported that guidewire break occurred.The target lesion was located in a non-tortuous right anterior tibial artery.During procedure, v14 wire and non-boston scientific catheter were advanced into the artery, and vessel was inflated by a 3mm balloon.Upon removal, broken piece seen on angiogram.The broken piece was retrieved with the catheter and removed from the patient.The procedure was completed using an alternate method.No patient complications were reported.

• 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: 21308399
• Report Number: 2124215-2025-04439
• Device Sequence Number: 8169234
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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 Expiration Date: 09/02/2026
• Device Model Number: H74939216730020
• Device Catalogue Number: H74939216730020
• Device Lot Number: 0034761789
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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: MICROCATHETER: QUICK CROSS; MICROCATHETER: QUICK CROSS
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 68 KG