MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event estimated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the guidewire tip broke.A 200cm, 8cm poly tip v-18 control wire was selected for a procedure.During the procedure, however, it was noted that the tip of the wire broke off.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event estimated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the guidewire tip broke.A 200cm, 8cm poly tip v-18 control wire was selected for a procedure.During the procedure, however, it was noted that the tip of the wire broke off.There were no patient complications reported.It was further reported that the anatomical location was in the popliteal artery, and the wire was used in a popliteal dilatation procedure.The physician had used the wire but realized the tip was missing when he had tried to reuse it.Another guidewire was used to complete the procedure, and there were no patient complications.

• Brand Name: V-18 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: 21161135
• Report Number: 2124215-2024-83865
• Device Sequence Number: 8520954
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033742
• 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): 02/10/2025

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: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0035175870
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 10/29/2024
• 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
• Patient Sex: Unknown