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

Model Number	40458
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the guidewire broke.A v-14 control wire and carotid wallstent were selected for use.The carotid wallstent was positioned for deployment in the target lesion.However, the v-14 control wire was unable to advance and then broke.Both devices were removed together, and new devices were used to complete the procedure.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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17137667
• Report Number: 2124215-2023-29970
• Device Sequence Number: 6021307
• Product Code: DQX
• UDI-Device Identifier: 08714729799245
• UDI-Public: 08714729799245
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/15/2023

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: 10/19/2023
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0028227138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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