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

Model Number	40495
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and coating issue occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of below the knee.A 300cm, 8cm poly tip v-18 control wire was selected for use.During the procedure, the tip of the wire was trapped by calcification.Upon withdrawal, the coating peeled off.When checked outside the patient, unusual resistance was also felt.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that removal difficulty and coating issue occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of below the knee.A 300cm, 8cm poly tip v-18 control wire was selected for use.During the procedure, the tip of the wire was trapped by calcification.Upon withdrawal, the coating peeled off.When checked outside the patient, unusual resistance was also felt.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that during withdrawal, strong resistance was encountered, and there was concern that the device may separate.The microcatheter was pressed against the lesion as much as possible and the device was carefully withdrawn in a simple pull-out manner, ensuring that even in the event of separation, it would remain inside the microcatheter.Upon inspection outside the body, the coating at the distal tip of the device appeared to be damaged, and use was discontinued.

• 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: 23656928
• Report Number: 2124215-2025-84227
• Device Sequence Number: 17349582
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)270619(10)36798656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/18/2025

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: 0036798656
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 06/19/2025
• 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: INTRODUCER SHEATH - PARENT45; INTRODUCER SHEATH - PARENT45; MICRO CATHETER - PROMINENT RAPTOR; MICRO CATHETER - PROMINENT RAPTOR
• Patient Sex: Unknown