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

Model Number	40495
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the guidewire was returned to our post market quality assurance laboratory.Visual inspection was performed, and it was observed that it was kinked and detached at distal tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21oct2025.It was reported that device kink occurred.The 50-60% stenosed target lesion was located in the severely tortuous and moderately calcified superficial femoral artery.A 200cm, 8cm v-18 control wire was selected for percutaneous transluminal angioplasty (pta).However, during the procedure, it was noted that the wire was kinked.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed distal tip detachment.
Additional Manufacturer Narrative
Correction to field e1: initial reporter phone from +011(082)1067958965 to +011(082)07043258954 updated e1: initial reporter email.Device evaluated by mfr: the guidewire was returned to our post market quality assurance laboratory.Visual inspection was performed, and it was observed that it was kinked and detached at distal tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21oct2025.It was reported that device kink occurred.The 50-60% stenosed target lesion was located in the severely tortuous and moderately calcified superficial femoral artery.A 200cm, 8cm v-18 control wire was selected for percutaneous transluminal angioplasty (pta).However, during the procedure, it was noted that the wire was kinked.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed distal tip detachment.

• 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: 23576247
• Report Number: 2124215-2025-83080
• Device Sequence Number: 9304849
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: (01)08714729070191(17)261218(10)35520821
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 0035520821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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 Age: 66 YR
• Patient Sex: Male